Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-03-05 @ 11:54 AM
Study NCT ID:
NCT04981366
Status:
COMPLETED
Last Update Posted:
2025-06-13
First Post:
2021-07-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Protein Supplementation in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction and Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hars@usp.br', 'phone': '+55 11 30618789', 'title': 'Prof. Hamilton Roschel', 'organization': 'University of São Paulo'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '16 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 8, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 8, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 8, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Articular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fell during exercise training', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Transitory pain after muscle biopsies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising after muscle biopsies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Third-degree atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Fat-free Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '49.6', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '50.3', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '50.5', 'spread': '5.1', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '52.5', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '52.7', 'spread': '4.3', 'groupId': 'OG001'}, {'value': '49.3', 'spread': '4.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': "We applied the restricted maximum likelihood, compound symmetry covariance structure, and Kenward-Roger degrees of freedom approximation. To maintain the significance level at 0.05, the primary endpoints were assessed using Hochberg's procedure.", 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Fat-free mass evaluated through dual-energy x-ray absorptiometry (DEXA) and reported as percentage', 'unitOfMeasure': 'percentage of fat-free mass', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Appendicular Fat-free Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '17.7', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '18.0', 'spread': '3.7', 'groupId': 'OG001'}, {'value': '17.4', 'spread': '3.6', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '18.1', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '17.6', 'spread': '3.5', 'groupId': 'OG001'}, {'value': '16.5', 'spread': '2.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': "We applied the restricted maximum likelihood, compound symmetry covariance structure, and Kenward-Roger degrees of freedom approximation. To maintain the significance level at 0.05, the primary endpoints were assessed using Hochberg's procedure.", 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Appendicular fat-free mass was evaluated through dual-energy x-ray absorptiometry (DEXA) and calculated as the sum of the fat-free mass of the upper and lower limbs.', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Appendicular Fat-free Mass to Body Mass Index Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '0.51', 'spread': '0.10', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '0.48', 'spread': '0.09', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'The appendicular fat-free mass (AFFM) was assessed using dual-energy X-ray absorptiometry (DXA) and expressed in kilograms (kg). The body mass index (BMI) was calculated as weight in kilograms divided by the square of height in meters (kg/m²). The AFFM/BMI ratio was computed by dividing AFFM (kg) by BMI (kg/m²), resulting in a unitless ratio. Higher values indicate greater muscle mass relative to body size', 'unitOfMeasure': 'Kg/Kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Leg Fat-free Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '13.5', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '2.7', 'groupId': 'OG001'}, {'value': '13.2', 'spread': '2.7', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '13.8', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '12.5', 'spread': '2.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': "We applied the restricted maximum likelihood, compound symmetry covariance structure, and Kenward-Roger degrees of freedom approximation. To maintain the significance level at 0.05, the primary endpoints were assessed using Hochberg's procedure.", 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Appendicular fat-free mass was evaluated through dual-energy x-ray absorptiometry (DEXA) and calculated as the sum of the fat-free mass of the lower limbs.', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fat-mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '48.6', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '47.8', 'spread': '4.9', 'groupId': 'OG001'}, {'value': '47.7', 'spread': '5.2', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '45.6', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '45.4', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '48.9', 'spread': '4.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Fat mass was evaluated trough dual-energy x-ray absorptiometry (DEXA) and reported as percentage.', 'unitOfMeasure': 'percentage of fat mass', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quadriceps Cross-sectional Area (CSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nsocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '51.7', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '50.7', 'spread': '12.1', 'groupId': 'OG001'}, {'value': '50.1', 'spread': '14.4', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '54.3', 'spread': '13.4', 'groupId': 'OG000'}, {'value': '51.9', 'spread': '12.9', 'groupId': 'OG001'}, {'value': '47.7', 'spread': '11.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Quadriceps cross-sectional area (CSA) was assessed by computed tomography imaging', 'unitOfMeasure': 'cm²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rectus Femoris Cross-sectional Area (CSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nsocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '3.39', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '3.23', 'spread': '0.96', 'groupId': 'OG001'}, {'value': '3.32', 'spread': '1.21', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '3.45', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '3.27', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '3.10', 'spread': '0.98', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Rectus femoris cross-sectional area (CSA) was assessed by B-mode ultrasound.', 'unitOfMeasure': 'cm²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Vastus Lateralis Cross-sectional Area (CSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nsocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '12.32', 'spread': '2.69', 'groupId': 'OG000'}, {'value': '12.15', 'spread': '2.84', 'groupId': 'OG001'}, {'value': '12.13', 'spread': '3.53', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '12.55', 'spread': '2.84', 'groupId': 'OG000'}, {'value': '12.45', 'spread': '2.77', 'groupId': 'OG001'}, {'value': '11.49', 'spread': '2.81', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Vastus lateralis cross-sectional area (CSA) was assessed by B-mode ultrasound.', 'unitOfMeasure': 'cm²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Muscle Fiber Cross-sectional Area (fCSA)- Type I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nsocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '2240.7', 'spread': '901.5', 'groupId': 'OG000'}, {'value': '2725.8', 'spread': '1121.6', 'groupId': 'OG001'}, {'value': '2669.4', 'spread': '806.7', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '3108.6', 'spread': '1212.8', 'groupId': 'OG000'}, {'value': '2859.4', 'spread': '948.67', 'groupId': 'OG001'}, {'value': '2614.6', 'spread': '1076.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Muscle fiber cross-sectional area (type I) was assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy', 'unitOfMeasure': 'µm²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This exploratory subgroup analysis included only participants who consented to undergo a muscle biopsy (n = 20 out of 105 total participants).'}, {'type': 'SECONDARY', 'title': 'Muscle Fiber Cross-sectional Area (fCSA)- Type II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nsocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '2175.6', 'spread': '827.6', 'groupId': 'OG000'}, {'value': '2401.4', 'spread': '1108.8', 'groupId': 'OG001'}, {'value': '2340.8', 'spread': '921.2', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '2775.2', 'spread': '964.1', 'groupId': 'OG000'}, {'value': '2239.5', 'spread': '724.8', 'groupId': 'OG001'}, {'value': '2166.1', 'spread': '979.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Muscle fiber cross-sectional area (type II) was assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy', 'unitOfMeasure': 'µm²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This exploratory subgroup analysis included only participants who consented to undergo a muscle biopsy (n = 20 out of 105 total participants).'}, {'type': 'SECONDARY', 'title': 'Serum Levels of C-terminal Telopeptide of Type I Collagen (CTX-I)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '0.34', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '0.35', 'spread': '0.13', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '0.35', 'spread': '0.12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Bone turnover was assessed by an automated electrochemiluminescence method.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Levels of Procollagen Type I N-terminal Propeptide - (P1NP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '53.1', 'spread': '21.2', 'groupId': 'OG000'}, {'value': '61.0', 'spread': '26.9', 'groupId': 'OG001'}, {'value': '56.3', 'spread': '22.8', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '66.2', 'spread': '61.0', 'groupId': 'OG000'}, {'value': '66.1', 'spread': '32.2', 'groupId': 'OG001'}, {'value': '56.8', 'spread': '22.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Bone turnover was assessed by an automated electrochemiluminescence method.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bone Mineral Density (Whole-body)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '1.08', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '1.05', 'spread': '0.12', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '1.06', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '1.05', 'spread': '0.11', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.033', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'bone mineral density (whole-body) evaluated trough dual-energy x-ray absorptiometry (DEXA)', 'unitOfMeasure': 'g/cm²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bone Mineral Density (Femur Neck)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '0.74', 'spread': '0.11', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '0.74', 'spread': '0.11', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.944', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'bone mineral density (femur neck) evaluated trough dual-energy x-ray absorptiometry (DEXA)', 'unitOfMeasure': 'g/cm²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bone Mineral Density (Total Hip)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '0.90', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '0.89', 'spread': '0.13', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '0.90', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '0.88', 'spread': '0.13', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.203', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'bone mineral density (total hip) evaluated trough dual-energy x-ray absorptiometry (DEXA)', 'unitOfMeasure': 'g/cm²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bone Mineral Density (Lumbar Spine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '0.98', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '0.96', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '0.97', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '0.96', 'spread': '0.14', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.027', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'bone mineral density (lumbar spine) evaluated trough dual-energy x-ray absorptiometry (DEXA)', 'unitOfMeasure': 'g/cm²', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bone Microarchitecture (Total Volumetric Density)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '331.9', 'spread': '82.0', 'groupId': 'OG000'}, {'value': '309.5', 'spread': '58.9', 'groupId': 'OG001'}, {'value': '324.7', 'spread': '75.4', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '340.2', 'spread': '85.2', 'groupId': 'OG000'}, {'value': '308.6', 'spread': '66.8', 'groupId': 'OG001'}, {'value': '328.9', 'spread': '72.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.145', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Bone microarchitecture (total volumetric density) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)', 'unitOfMeasure': 'mg HA/cm³', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bone Microarchitecture (Trabecular Volumetric Density)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '147.7', 'spread': '37.8', 'groupId': 'OG000'}, {'value': '309.5', 'spread': '58.9', 'groupId': 'OG001'}, {'value': '324.7', 'spread': '75.4', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '152.0', 'spread': '37.9', 'groupId': 'OG000'}, {'value': '308.6', 'spread': '66.8', 'groupId': 'OG001'}, {'value': '328.9', 'spread': '72.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Bone microarchitecture (trabecular volumetric density) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)', 'unitOfMeasure': 'mg HA/cm³', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bone Microarchitecture (Cortical Volumetric Density)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '969.9', 'spread': '59.8', 'groupId': 'OG000'}, {'value': '951.0', 'spread': '76.1', 'groupId': 'OG001'}, {'value': '972.8', 'spread': '60.3', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '969.9', 'spread': '62.5', 'groupId': 'OG000'}, {'value': '948.7', 'spread': '76.3', 'groupId': 'OG001'}, {'value': '975.5', 'spread': '57.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.551', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Bone microarchitecture (cortical volumetric density) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)', 'unitOfMeasure': 'mg HA/cm³', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bone Microarchitecture (BV/TV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '12.5', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '12.2', 'spread': '3.0', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '12.7', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '12.3', 'spread': '3.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'Bone microarchitecture (BV/TV) was assessed at the distal region of the radius of the non-dominant limb using high-resolution peripheral quantitative computed tomography (HR-pQCT). Specifically, trabecular bone volume fraction (BV/TV) is computed as the ratio of the trabecular bone mineral density (Tb.vBMD in mg HA/cm3) and 1200 mg HA/cm3, which is assumed to be the density of fully mineralized bone. Afterwards, the values were multiplied by 100 to reflect the percentage of trabecular bone volume fraction.', 'unitOfMeasure': 'percentage of trabecular bone volume', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bone Microarchitecture (Trabecular Number - Tb. N)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '1.86', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '1.96', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '1.90', 'spread': '0.38', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '1.90', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '1.93', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '1.90', 'spread': '0.35', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'The trabecular number (Tb.N) was analyzed using the ridge extraction technique in high-resolution peripheral quantitative computed tomography (HR-pQCT). In this approach, the trabeculae were treated as elongated structures resembling ridges. The technique involves detecting the central axis (ridge) of each trabecular element in a 3D image.', 'unitOfMeasure': 'Trabeculae per mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bone Microarchitecture (Trabecular Separation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '0.493', 'spread': '0.127', 'groupId': 'OG000'}, {'value': '0.459', 'spread': '0.092', 'groupId': 'OG001'}, {'value': '0.488', 'spread': '0.132', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '0.474', 'spread': '0.101', 'groupId': 'OG000'}, {'value': '0.474', 'spread': '0.106', 'groupId': 'OG001'}, {'value': '0.469', 'spread': '0.117', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Trabecular separation (Tb.Sp), represents the average distance between trabeculae in the trabecular bone region. It was assessed using the distance transformation method, applied to the background (void space) of the trabecular structure. The transformation method measures the distance from each voxel (3D pixel) in the void space to the nearest trabecular element, and the average of these distances is then calculated. This method enables precise quantification of trabecular spacing in high-resolution 3D images.\n\nThe separation is inversely related to trabecular density, as closer trabeculae indicate a higher bone volume fraction (BV/TV) and a denser bone network. The calculation of trabecular separation can be expressed as:\n\nTb.Sp = 1- BV/TV : Tb.N', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bone Microarchitecture (Trabecular Thickness)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '0.066', 'spread': '0.014', 'groupId': 'OG000'}, {'value': '0.066', 'spread': '0.013', 'groupId': 'OG001'}, {'value': '0.066', 'spread': '0.012', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '0.064', 'spread': '0.013', 'groupId': 'OG000'}, {'value': '0.068', 'spread': '0.012', 'groupId': 'OG001'}, {'value': '0.067', 'spread': '0.011', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Trabecular thickness (Tb.Th) represents the average thickness of trabecular bone elements. It was assessed by calculating the mean thickness of the segmented trabecular structure, using the distance transformation method applied to the trabecular bone tissue.\n\nThe trabecular thickness is calculated as a ratio of the bone volume fraction (BV/TV) to trabecular number (Tb.N): Tb.Th =BV/TV : Tb.N', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bone Microarchitecture (Cortical Porosity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '3.5', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '3.2', 'spread': '2.4', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '2.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': "Cortical porosity (Ct.Po) is quantified using a density-based approach that segments bone into three compartments: compact cortex, transitional zone, and trabecular compartment. Voxels with a density below 1000 mg HA/cm³ indicate the presence of void space (pores), and porosity is estimated as the ratio of void space in each voxel. The mean of this ratio is calculated across all voxels in the compartment of interest, and the values were multiplied by 100. This method captures pores with diameters below the scanner's spatial resolution but relies on the assumption of fixed bone tissue mineral density and may be susceptible to image noise and beam hardening.", 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bone Microarchitecture (Cortical Thickness)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '0.958', 'spread': '0.242', 'groupId': 'OG000'}, {'value': '0.827', 'spread': '0.201', 'groupId': 'OG001'}, {'value': '0.908', 'spread': '0.193', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '0.968', 'spread': '0.240', 'groupId': 'OG000'}, {'value': '0.826', 'spread': '0.203', 'groupId': 'OG001'}, {'value': '0.911', 'spread': '0.203', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.344', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Bone microarchitecture (cortical thickness) wwas assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bone Microarchitecture (Cortical Pore Diameter)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '0.168', 'spread': '0.038', 'groupId': 'OG000'}, {'value': '0.172', 'spread': '0.043', 'groupId': 'OG001'}, {'value': '0.169', 'spread': '0.029', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '0.166', 'spread': '0.038', 'groupId': 'OG000'}, {'value': '0.174', 'spread': '0.038', 'groupId': 'OG001'}, {'value': '0.171', 'spread': '0.030', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.613', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Bone microarchitecture (cortical pore diameter) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bone Microarchitecture (Stiffness)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '72.7', 'spread': '20', 'groupId': 'OG000'}, {'value': '74.1', 'spread': '18.6', 'groupId': 'OG001'}, {'value': '71.6', 'spread': '20.2', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '73.5', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '75.1', 'spread': '19.6', 'groupId': 'OG001'}, {'value': '69.7', 'spread': '18.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.944', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Stiffness (kN/mm) is defined as the total reaction force of the model divided by the applied displacement. It represents the resistance of a material or structure to deformation under an applied load. A higher stiffness value indicates greater resistance to deformation, while a lower value suggests more flexibility.', 'unitOfMeasure': 'kN/mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bone Microarchitecture (Estimated Failure Load)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '3458', 'spread': '910', 'groupId': 'OG000'}, {'value': '3553', 'spread': '888', 'groupId': 'OG001'}, {'value': '3430', 'spread': '948', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '3503', 'spread': '860', 'groupId': 'OG000'}, {'value': '3598', 'spread': '940', 'groupId': 'OG001'}, {'value': '3347', 'spread': '863', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.601', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Estimated failure load is indirectly calculated from linear finite element (FE) models using a yield criterion. The failure load is estimated when a specified volume of bone tissue (critical volume) exceeds a critical strain threshold, at which point the model is assumed to have yielded. This approach is often based on the Pistoia criterion, which is used to predict the point of failure in the material based on its mechanical properties and deformation behavior.', 'unitOfMeasure': 'kN', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Isometric Muscle Strength - Handgrip', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '18.57', 'spread': '5.44', 'groupId': 'OG000'}, {'value': '19.29', 'spread': '5.84', 'groupId': 'OG001'}, {'value': '19.86', 'spread': '5.62', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '23.17', 'spread': '5.38', 'groupId': 'OG000'}, {'value': '23.71', 'spread': '4.82', 'groupId': 'OG001'}, {'value': '18.43', 'spread': '5.07', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Isometric muscle strength was evaluated using a handgrip dynamometer (Jamar®, Sammons Preston Rolyan, USA).', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Muscle Strength - Upper Limbs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '21.9', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '23.2', 'spread': '8.4', 'groupId': 'OG001'}, {'value': '23.2', 'spread': '8.6', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '26.9', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '28.1', 'spread': '8.7', 'groupId': 'OG001'}, {'value': '19.2', 'spread': '7.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Muscle strength was evaluated using maximal dynamic strength test \\[1RM\\])', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Muscle Strength - Lower Limbs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '99.9', 'spread': '35.6', 'groupId': 'OG000'}, {'value': '99.6', 'spread': '35.7', 'groupId': 'OG001'}, {'value': '106.9', 'spread': '43.0', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '120.8', 'spread': '39.7', 'groupId': 'OG000'}, {'value': '124.8', 'spread': '36.5', 'groupId': 'OG001'}, {'value': '94.3', 'spread': '43.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Muscle strength was evaluated using maximal dynamic strength test \\[1RM\\])', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Muscle Function (Short Physical Performance Battery)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '8.9', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '9.3', 'spread': '1.6', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '10.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '1.9', 'groupId': 'OG001'}, {'value': '9.0', 'spread': '1.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Muscle function evaluated through battery of tests - Short Physical Performance Battery (SPPB). The SPPB is a standardized assessment of lower extremity function that includes three components: balance tests, gait speed over 4 meters, and the five-times sit-to-stand test. Each component is scored from 0 to 4, with a total score ranging from 0 to 12. Higher scores indicate better physical performance. The SPPB is widely used to evaluate physical function, predict disability, and monitor health status in older adults.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Muscle Function (30-s Sit-to-stand Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '10.3', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '10.4', 'spread': '3.1', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '12.8', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '12.4', 'spread': '3.5', 'groupId': 'OG001'}, {'value': '10.2', 'spread': '2.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'The 30-second sit-to-stand test is a simple measure of lower body strength and functional capacity. Participants are asked to rise from a seated position and sit back down as many times as possible within 30 seconds. The total number of complete sit-to-stand repetitions performed in the given time is recorded. This test is commonly used to assess physical fitness and mobility, particularly in older adults or individuals with health conditions.', 'unitOfMeasure': 'number of repetitions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Muscle Function (Timed-up-and-go)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '9.76', 'spread': '4.10', 'groupId': 'OG000'}, {'value': '10.91', 'spread': '4.26', 'groupId': 'OG001'}, {'value': '8.67', 'spread': '1.79', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '8.49', 'spread': '2.97', 'groupId': 'OG000'}, {'value': '9.01', 'spread': '4.37', 'groupId': 'OG001'}, {'value': '9.38', 'spread': '1.84', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'The Timed Up and Go (TUG) test is a simple and widely used assessment of mobility and balance. Participants are asked to stand up from a seated position, walk 3 meters, turn around, walk back to the chair, and sit down again, all as quickly as possible. The total time taken to complete the task is recorded. The TUG test is commonly used to evaluate functional mobility, fall risk, and the ability to perform daily activities, particularly in older adults or individuals with mobility impairments.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Muscle Function (Gait Speed)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '0.95', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '0.25', 'groupId': 'OG001'}, {'value': '0.98', 'spread': '0.18', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '1.13', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '0.97', 'spread': '0.18', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': "Muscle function evaluated through 4-m gait speed test. The 4-meter usual gait speed test measures the time it takes for a participant to walk a distance of 4 meters at their usual pace. The test is commonly used to assess walking speed, which is an important indicator of mobility, physical function, and overall health. The time taken to complete the 4-meter walk is recorded and used to evaluate the individual's functional capacity, with slower times potentially indicating mobility impairments or a higher risk of adverse health outcomes.", 'unitOfMeasure': 'm/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cardiorespiratory Fitness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '16.0', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '17.7', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '17.6', 'spread': '3.6', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '19.2', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '20', 'spread': '2.6', 'groupId': 'OG001'}, {'value': '17.9', 'spread': '3.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': 'Cardiorespiratory fitness was evaluated by maximal oxygen uptake (VO²max) during a maximal exercise test on a treadmill', 'unitOfMeasure': 'mL/Kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Insulin Sensitivity as Assessed by Surrogates of Insulin Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '0.1', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '2.5', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) is a method used to estimate insulin resistance based on fasting plasma glucose and fasting insulin levels. It is calculated using the following formula:\n\nHOMA-IR = (fasting insulin \\[µU/mL\\] × fasting glucose \\[mg/dL\\]) / 405. Higher values of HOMA-IR indicate greater insulin resistance and are considered worse. There is no fixed theoretical maximum value, but typical reference ranges in healthy individuals are usually \\<2. Values above this threshold may suggest impaired insulin sensitivity or metabolic dysfunction. The HOMA-IR is widely used in clinical and research settings as a surrogate marker for insulin resistance.', 'unitOfMeasure': 'Index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Brachial Flow-mediated Dilation (FMD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '5', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '7.8', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '0.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Brachial flow-mediated dilation (FMD) is a non-invasive measure of endothelial function, assessed using high-resolution B-mode ultrasound. The test evaluates the percent change in brachial artery diameter in response to increased blood flow (reactive hyperemia) following 3 minutes of cuff occlusion, on the forearm. An increase in arterial diameter after cuff release indicates vasodilation mediated by nitric oxide. Higher FMD values reflect better endothelial function, whereas lower values are associated with cardiovascular risk and impaired vascular health.', 'unitOfMeasure': 'percentage of flow mediated dilatation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Lipid Profile (HDL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '52.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '52.8', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '52.8', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '51.4', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '51.5', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '51.7', 'spread': '0.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.949', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Lipid Profile (LDL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '116.1', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '115.5', 'spread': '3.5', 'groupId': 'OG001'}, {'value': '116.8', 'spread': '3.5', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '111.1', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '111.4', 'spread': '3.6', 'groupId': 'OG001'}, {'value': '112.3', 'spread': '3.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.993', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Lipid Profile (VLDL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '25.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '25.4', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '25.1', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '22.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '22.8', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '23.9', 'spread': '0.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.601', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Lipid Profile (Triglycerides)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '140.4', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '141.1', 'spread': '5', 'groupId': 'OG001'}, {'value': '138.8', 'spread': '5.1', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '119.0', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '122.5', 'spread': '5.3', 'groupId': 'OG001'}, {'value': '130.8', 'spread': '5.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.408', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Telomere Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '0.98', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '0.05', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '0.99', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '0.05', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.082', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Relative telomere length was measured using quantitative polymerase chain reaction (qPCR), which determines the ratio of telomeric repeat copy number (T) to a single-copy gene number (S) in a given sample. This T/S ratio is a unitless index that reflects the average telomere length relative to the reference gene. Higher T/S ratios indicate longer telomeres, while lower values indicate shorter telomeres. Although the T/S ratio does not provide absolute telomere length in base pairs, it is a widely used, validated method to assess relative telomere length in epidemiological and clinical research.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Oxidative Stress - Superoxide Dismutase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '22.6', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '21.5', 'spread': '4.0', 'groupId': 'OG001'}, {'value': '21.5', 'spread': '5.5', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '23.2', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '23.3', 'spread': '4.1', 'groupId': 'OG001'}, {'value': '22.6', 'spread': '4.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.550', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': "Superoxide dismutase (SOD) activity was measured using an enzyme-linked immunosorbent assay (ELISA), following the manufacturer's instructions. The assay is based on the competitive binding of SOD present in the sample and a SOD standard to a monoclonal antibody coated on a microplate.", 'unitOfMeasure': 'percentage inhibition per 2 µL of samp', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Oxidative Stress - Catalase Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '6.2', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '5.8', 'spread': '2.7', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '6.0', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '5.7', 'spread': '2.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.700', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': "Catalase activity was assessed using an enzyme-linked immunosorbent assay (ELISA), according to the manufacturer's protocol. The assay quantifies catalase based on the competition between the sample catalase and a catalase standard for binding to specific antibodies coated on the microplate. The detection is achieved through a colorimetric reaction measured at a specific wavelength.", 'unitOfMeasure': 'U/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Oxidative Stress - Glutathione Peroxidase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '404.2', 'spread': '52.8', 'groupId': 'OG000'}, {'value': '406.5', 'spread': '49.5', 'groupId': 'OG001'}, {'value': '401.2', 'spread': '40.7', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '416.3', 'spread': '45.7', 'groupId': 'OG000'}, {'value': '412.5', 'spread': '47.9', 'groupId': 'OG001'}, {'value': '396.1', 'spread': '39.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.254', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': "Glutathione peroxidase activity was measured using a colorimetric assay according to the manufacturer's instructions. The method is based on the enzyme-catalyzed reduction of hydrogen peroxide by reduced glutathione (GSH), forming oxidized glutathione (GSSG). In the presence of glutathione reductase and NADPH, GSSG is converted back to GSH with concomitant oxidation of NADPH to NADP⁺.", 'unitOfMeasure': 'µmol GSH/min/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Oxidative Stress - Glutathione Reductase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '48.7', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '48.0', 'spread': '3.0', 'groupId': 'OG001'}, {'value': '48.4', 'spread': '2.4', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '49.6', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '47.3', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '49.1', 'spread': '2.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.373', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Oxidative stress markers (SOD, CAT, glutathione, GPx, GST and TBARS) were assessed through ELISA assay.', 'unitOfMeasure': 'µmol NADPH/min/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Oxidative Stress - Glutathione S-transferases', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '17.4', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '18.7', 'spread': '11.6', 'groupId': 'OG001'}, {'value': '18.3', 'spread': '9.3', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '21.3', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '9.6', 'groupId': 'OG001'}, {'value': '18.6', 'spread': '9.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.407', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Glutathione S-transferase (GST) activity was assessed using a colorimetric assay based on the conjugation of the substrate 1-chloro-2,4-dinitrobenzene (CDNB) with reduced glutathione (GSH). The reaction results in a yellow product that is quantified by measuring the absorbance at 340 nm.', 'unitOfMeasure': 'pmol GSH conjugates/min/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Oxidative Stress - Thiobarbituric Acid Reactive Substances', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '2.05', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '2.06', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '1.94', 'spread': '0.52', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '1.97', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '2.15', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '2.25', 'spread': '0.97', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.051', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': "Thiobarbituric Acid Reactive Substances (TBARS): Lipid peroxidation was assessed by measuring thiobarbituric acid reactive substances (TBARS), following the manufacturer's instructions. This colorimetric assay detects malondialdehyde (MDA), a byproduct of lipid peroxidation, which reacts with thiobarbituric acid to form a colored complex measurable at 532-535 nm. Results are expressed as micromoles of MDA equivalents per liter (µmol/L), with higher values indicating greater oxidative stress.", 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was conducted in a subsample of participants who completed the study protocol. Two participants from the CREX+PTN group and two participants from the CREX+PLA group were excluded from the analysis due to sample quality issues.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Inflammatory Profile - IL1β', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '1.45', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '1.33', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '1.01', 'spread': '0.38', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '1.46', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '1.22', 'spread': '0.38', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.385', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Inflammatory Profile - IL-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '3.75', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '4.46', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '3.56', 'spread': '0.77', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '3.78', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '2.47', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '3.96', 'spread': '0.77', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.239', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Inflammatory Profile - IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '3.30', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '2.99', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '2.92', 'spread': '0.47', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '2.49', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '2.49', 'spread': '0.46', 'groupId': 'OG001'}, {'value': '3.25', 'spread': '0.47', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.463', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Inflammatory Profile - TNF-α', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '20.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '19.6', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '19.4', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '14.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '20.1', 'spread': '1.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.032', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Inflammatory Profile - C-Reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '5.76', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '5.19', 'spread': '0.81', 'groupId': 'OG001'}, {'value': '6.01', 'spread': '0.83', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '4.25', 'spread': '0.87', 'groupId': 'OG000'}, {'value': '5.74', 'spread': '0.86', 'groupId': 'OG001'}, {'value': '5.54', 'spread': '0.87', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.469', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Inflammatory profile (i.e.; C-Reactive Protein ) was quantified via an immunoturbidimetric assay.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Area Under the Curve (AUC) of Blood Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nsocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '683.54', 'groupId': 'OG000', 'lowerLimit': '617.38', 'upperLimit': '749.70'}, {'value': '641.73', 'groupId': 'OG001', 'lowerLimit': '574.51', 'upperLimit': '708.94'}, {'value': '648.99', 'groupId': 'OG002', 'lowerLimit': '581.77', 'upperLimit': '716.20'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '599.51', 'groupId': 'OG000', 'lowerLimit': '533.35', 'upperLimit': '665.66'}, {'value': '622.22', 'groupId': 'OG001', 'lowerLimit': '555.00', 'upperLimit': '689.43'}, {'value': '638.20', 'groupId': 'OG002', 'lowerLimit': '570.98', 'upperLimit': '705.41'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'The area under the curve (AUC) of blood glucose was measured during a 2-hour oral glucose tolerance test (OGTT). Blood samples were collected at baseline (0 minutes, following a 12-hour overnight fast), and at 30, 60, 90, and 120 minutes after ingestion of a 75 g glucose bolus. The AUC was calculated using these time points (0, 30, 60, 90, and 120 minutes) to assess the blood glucose response over the 2-hour period following glucose ingestion.', 'unitOfMeasure': 'mg·min/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Area Under the Curve (AUC) of Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nsocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '442.08', 'groupId': 'OG000', 'lowerLimit': '355.59', 'upperLimit': '528.58'}, {'value': '417.23', 'groupId': 'OG001', 'lowerLimit': '329.35', 'upperLimit': '505.11'}, {'value': '432.69', 'groupId': 'OG002', 'lowerLimit': '344.81', 'upperLimit': '520.57'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '259.90', 'groupId': 'OG000', 'lowerLimit': '173.40', 'upperLimit': '346.39'}, {'value': '310.21', 'groupId': 'OG001', 'lowerLimit': '222.34', 'upperLimit': '398.09'}, {'value': '403.40', 'groupId': 'OG002', 'lowerLimit': '315.52', 'upperLimit': '491.28'}]}]}], 'analyses': [{'pValue': '0.064', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'The area under the curve (AUC) of insulin was measured during a 2-hour oral glucose tolerance test (OGTT). Blood samples were collected at baseline (0 minutes, following a 12-hour overnight fast), and at 30, 60, 90, and 120 minutes after ingestion of a 75 g glucose bolus. The AUC was calculated using these time points (0, 30, 60, 90, and 120 minutes) to assess the insulin response over the 2-hour period following glucose ingestion.', 'unitOfMeasure': 'μU·min/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '6.8', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '4.4', 'spread': '3.8', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '4.6', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '5.3', 'groupId': 'OG001'}, {'value': '4.0', 'spread': '4.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0314', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Anxiety was assessed using the Geriatric Anxiety Inventory (GAI), a 20-item self-report questionnaire designed to measure anxiety symptoms in older adults. The total score ranges from 0 to 20, with higher scores reflecting more severe anxiety symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '4.1', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '4.4', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '2.6', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '4.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0147', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Depression was assessed using the Geriatric Depression Scale (GDS-15), a 15-item self-report questionnaire designed to measure depressive symptoms in older adults. The total score ranges from 0 to 15, with higher scores indicating more severe depression.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Health-related Quality of Life - Physical Component', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '61.2', 'spread': '24.3', 'groupId': 'OG000'}, {'value': '63.9', 'spread': '22.1', 'groupId': 'OG001'}, {'value': '71.8', 'spread': '19.7', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '77.2', 'spread': '19.8', 'groupId': 'OG000'}, {'value': '77.2', 'spread': '19.5', 'groupId': 'OG001'}, {'value': '75.6', 'spread': '18.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Health-related quality of life was evaluated using the 36-Item Short Form Health Survey (SF-36), a widely used questionnaire designed to assess various dimensions of health in adults. The total score ranges from 0 to 100, with higher scores indicating better health-related quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Health-related Quality of Life - Mental Component', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '59.3', 'spread': '22.4', 'groupId': 'OG000'}, {'value': '58.9', 'spread': '23.3', 'groupId': 'OG001'}, {'value': '63.0', 'spread': '19.0', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '74.8', 'spread': '17.3', 'groupId': 'OG000'}, {'value': '81.5', 'spread': '13.4', 'groupId': 'OG001'}, {'value': '64.5', 'spread': '21.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Health-related quality of life was evaluated using the 36-Item Short Form Health Survey (SF-36), a widely used questionnaire designed to assess various dimensions of health in adults. The total score ranges from 0 to 100, with higher scores indicating better health-related quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Sleep Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'OG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'OG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '5.9', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '3.6', 'groupId': 'OG001'}, {'value': '5.6', 'spread': '3.0', 'groupId': 'OG002'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '4.6', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '5.0', 'spread': '3.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a self-report questionnaire that evaluates various aspects of sleep quality. The PSQI is scored by summing the scores of seven components, each ranging from 0 to 3. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'FG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'FG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Health issues unrelated to the trial', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment started: 2021-08-01 Recruitment finished: 2023-02-26'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Caloric Restriction Associated to Exercise Training Plus Protein Supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus protein supplementation.\n\nProtein supplement: 40g of whey protein in the breakfast;'}, {'id': 'BG001', 'title': 'Caloric Restriction Associated to Exercise Training Plus Isocaloric Placebo (CREX+PLA)', 'description': 'Patients allocated to this arm were submitted to caloric restriction associated with an exercise training program plus isocaloric placebo.\n\nisocaloric supplement: 42g of non-nitrogenous, isocaloric supplement in the breakfast;'}, {'id': 'BG002', 'title': 'Control Group (CTRL)', 'description': 'Patients allocated to this arm did not receive any intervention.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '72.2', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '71.8', 'spread': '5.6', 'groupId': 'BG001'}, {'value': '71.1', 'spread': '5.3', 'groupId': 'BG002'}, {'value': '71.7', 'spread': '5.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Participant age was recorded in years at the time of study enrollment', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index (kg/m²)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '36.0', 'spread': '4.8', 'groupId': 'BG000'}, {'value': '34.8', 'spread': '4.5', 'groupId': 'BG001'}, {'value': '34.5', 'spread': '4', 'groupId': 'BG002'}, {'value': '35.1', 'spread': '4.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Body mass index was calculated by dividing the body weight by squared height.', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total fat-free mass (%)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '49.6', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '50.3', 'spread': '4.8', 'groupId': 'BG001'}, {'value': '50.5', 'spread': '5.1', 'groupId': 'BG002'}, {'value': '50.2', 'spread': '5.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Total fat-free mass was evaluated using the dual X-ray absorptiometry', 'unitOfMeasure': 'Percentage', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Appendicular fat-free mass (kg)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '17.7', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '18.0', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '17.4', 'spread': '3.6', 'groupId': 'BG002'}, {'value': '17.7', 'spread': '3.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Appendicular fat-free mass was evaluated using dual X-ray absorptiometry and was considered as the sum of fat-free mass of upper and lower limbs.', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Appendicular fat-free mass to body mass index ratio', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.12', 'groupId': 'BG000'}, {'value': '0.52', 'spread': '0.11', 'groupId': 'BG001'}, {'value': '0.51', 'spread': '0.10', 'groupId': 'BG002'}, {'value': '0.51', 'spread': '0.11', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Appendicular fat-free mass/BMI was calculated as the ratio of appendicular fat-free mass to body mass index.', 'unitOfMeasure': 'Kg/Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Leg fat-free mass (kg)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '13.5', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '13.5', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '13.2', 'spread': '2.7', 'groupId': 'BG002'}, {'value': '13.4', 'spread': '2.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Leg fat-free mass was evaluated using dual X-ray absorptiometry and was considered as the sum of the fat-free mass of lower limbs.', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diabetes (n)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension (n)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Psychiatric diseases (n)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Rheumatic diseases (n)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Dyslipidemia (n)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Osteopenia (n)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-23', 'size': 626648, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-08T09:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2021-07-01', 'resultsFirstSubmitDate': '2025-03-26', 'studyFirstSubmitQcDate': '2021-07-22', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-28', 'studyFirstPostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Lipid Profile (HDL)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods'}, {'measure': 'Lipid Profile (LDL)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods'}, {'measure': 'Lipid Profile (VLDL)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods'}, {'measure': 'Lipid Profile (Triglycerides)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Lipid profile (i.e; HDL, LDL, VLDL, and triglycerides) were evaluated by colorimetric enzymatic methods'}, {'measure': 'Telomere Length', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Relative telomere length was measured using quantitative polymerase chain reaction (qPCR), which determines the ratio of telomeric repeat copy number (T) to a single-copy gene number (S) in a given sample. This T/S ratio is a unitless index that reflects the average telomere length relative to the reference gene. Higher T/S ratios indicate longer telomeres, while lower values indicate shorter telomeres. Although the T/S ratio does not provide absolute telomere length in base pairs, it is a widely used, validated method to assess relative telomere length in epidemiological and clinical research.'}, {'measure': 'Oxidative Stress - Superoxide Dismutase', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': "Superoxide dismutase (SOD) activity was measured using an enzyme-linked immunosorbent assay (ELISA), following the manufacturer's instructions. The assay is based on the competitive binding of SOD present in the sample and a SOD standard to a monoclonal antibody coated on a microplate."}, {'measure': 'Oxidative Stress - Catalase Activity', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': "Catalase activity was assessed using an enzyme-linked immunosorbent assay (ELISA), according to the manufacturer's protocol. The assay quantifies catalase based on the competition between the sample catalase and a catalase standard for binding to specific antibodies coated on the microplate. The detection is achieved through a colorimetric reaction measured at a specific wavelength."}, {'measure': 'Oxidative Stress - Glutathione Peroxidase', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': "Glutathione peroxidase activity was measured using a colorimetric assay according to the manufacturer's instructions. The method is based on the enzyme-catalyzed reduction of hydrogen peroxide by reduced glutathione (GSH), forming oxidized glutathione (GSSG). In the presence of glutathione reductase and NADPH, GSSG is converted back to GSH with concomitant oxidation of NADPH to NADP⁺."}, {'measure': 'Oxidative Stress - Glutathione Reductase', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Oxidative stress markers (SOD, CAT, glutathione, GPx, GST and TBARS) were assessed through ELISA assay.'}, {'measure': 'Oxidative Stress - Glutathione S-transferases', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Glutathione S-transferase (GST) activity was assessed using a colorimetric assay based on the conjugation of the substrate 1-chloro-2,4-dinitrobenzene (CDNB) with reduced glutathione (GSH). The reaction results in a yellow product that is quantified by measuring the absorbance at 340 nm.'}, {'measure': 'Oxidative Stress - Thiobarbituric Acid Reactive Substances', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': "Thiobarbituric Acid Reactive Substances (TBARS): Lipid peroxidation was assessed by measuring thiobarbituric acid reactive substances (TBARS), following the manufacturer's instructions. This colorimetric assay detects malondialdehyde (MDA), a byproduct of lipid peroxidation, which reacts with thiobarbituric acid to form a colored complex measurable at 532-535 nm. Results are expressed as micromoles of MDA equivalents per liter (µmol/L), with higher values indicating greater oxidative stress."}, {'measure': 'Inflammatory Profile - IL1β', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology.'}, {'measure': 'Inflammatory Profile - IL-10', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology.'}, {'measure': 'Inflammatory Profile - IL-6', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology.'}, {'measure': 'Inflammatory Profile - TNF-α', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Inflammatory profile (i.e.; IL1β, IL-10, IL-6, and TNF-α) were quantified using the Luminex xMAP technology.'}, {'measure': 'Inflammatory Profile - C-Reactive Protein', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Inflammatory profile (i.e.; C-Reactive Protein ) was quantified via an immunoturbidimetric assay.'}, {'measure': 'Area Under the Curve (AUC) of Blood Glucose', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'The area under the curve (AUC) of blood glucose was measured during a 2-hour oral glucose tolerance test (OGTT). Blood samples were collected at baseline (0 minutes, following a 12-hour overnight fast), and at 30, 60, 90, and 120 minutes after ingestion of a 75 g glucose bolus. The AUC was calculated using these time points (0, 30, 60, 90, and 120 minutes) to assess the blood glucose response over the 2-hour period following glucose ingestion.'}, {'measure': 'Area Under the Curve (AUC) of Insulin', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'The area under the curve (AUC) of insulin was measured during a 2-hour oral glucose tolerance test (OGTT). Blood samples were collected at baseline (0 minutes, following a 12-hour overnight fast), and at 30, 60, 90, and 120 minutes after ingestion of a 75 g glucose bolus. The AUC was calculated using these time points (0, 30, 60, 90, and 120 minutes) to assess the insulin response over the 2-hour period following glucose ingestion.'}, {'measure': 'Anxiety', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Anxiety was assessed using the Geriatric Anxiety Inventory (GAI), a 20-item self-report questionnaire designed to measure anxiety symptoms in older adults. The total score ranges from 0 to 20, with higher scores reflecting more severe anxiety symptoms.'}, {'measure': 'Depression', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Depression was assessed using the Geriatric Depression Scale (GDS-15), a 15-item self-report questionnaire designed to measure depressive symptoms in older adults. The total score ranges from 0 to 15, with higher scores indicating more severe depression.'}, {'measure': 'Health-related Quality of Life - Physical Component', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Health-related quality of life was evaluated using the 36-Item Short Form Health Survey (SF-36), a widely used questionnaire designed to assess various dimensions of health in adults. The total score ranges from 0 to 100, with higher scores indicating better health-related quality of life.'}, {'measure': 'Health-related Quality of Life - Mental Component', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Health-related quality of life was evaluated using the 36-Item Short Form Health Survey (SF-36), a widely used questionnaire designed to assess various dimensions of health in adults. The total score ranges from 0 to 100, with higher scores indicating better health-related quality of life.'}, {'measure': 'Sleep Quality', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a self-report questionnaire that evaluates various aspects of sleep quality. The PSQI is scored by summing the scores of seven components, each ranging from 0 to 3. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.'}], 'primaryOutcomes': [{'measure': 'Percentage of Fat-free Mass', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Fat-free mass evaluated through dual-energy x-ray absorptiometry (DEXA) and reported as percentage'}, {'measure': 'Appendicular Fat-free Mass', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Appendicular fat-free mass was evaluated through dual-energy x-ray absorptiometry (DEXA) and calculated as the sum of the fat-free mass of the upper and lower limbs.'}, {'measure': 'Appendicular Fat-free Mass to Body Mass Index Ratio', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'The appendicular fat-free mass (AFFM) was assessed using dual-energy X-ray absorptiometry (DXA) and expressed in kilograms (kg). The body mass index (BMI) was calculated as weight in kilograms divided by the square of height in meters (kg/m²). The AFFM/BMI ratio was computed by dividing AFFM (kg) by BMI (kg/m²), resulting in a unitless ratio. Higher values indicate greater muscle mass relative to body size'}, {'measure': 'Leg Fat-free Mass', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Appendicular fat-free mass was evaluated through dual-energy x-ray absorptiometry (DEXA) and calculated as the sum of the fat-free mass of the lower limbs.'}], 'secondaryOutcomes': [{'measure': 'Fat-mass', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Fat mass was evaluated trough dual-energy x-ray absorptiometry (DEXA) and reported as percentage.'}, {'measure': 'Quadriceps Cross-sectional Area (CSA)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Quadriceps cross-sectional area (CSA) was assessed by computed tomography imaging'}, {'measure': 'Rectus Femoris Cross-sectional Area (CSA)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Rectus femoris cross-sectional area (CSA) was assessed by B-mode ultrasound.'}, {'measure': 'Vastus Lateralis Cross-sectional Area (CSA)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Vastus lateralis cross-sectional area (CSA) was assessed by B-mode ultrasound.'}, {'measure': 'Muscle Fiber Cross-sectional Area (fCSA)- Type I', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Muscle fiber cross-sectional area (type I) was assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy'}, {'measure': 'Muscle Fiber Cross-sectional Area (fCSA)- Type II', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Muscle fiber cross-sectional area (type II) was assessed using an immunostaining assay of muscle tissue samples obtained through percutaneous muscle biopsy'}, {'measure': 'Serum Levels of C-terminal Telopeptide of Type I Collagen (CTX-I)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Bone turnover was assessed by an automated electrochemiluminescence method.'}, {'measure': 'Serum Levels of Procollagen Type I N-terminal Propeptide - (P1NP)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Bone turnover was assessed by an automated electrochemiluminescence method.'}, {'measure': 'Bone Mineral Density (Whole-body)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'bone mineral density (whole-body) evaluated trough dual-energy x-ray absorptiometry (DEXA)'}, {'measure': 'Bone Mineral Density (Femur Neck)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'bone mineral density (femur neck) evaluated trough dual-energy x-ray absorptiometry (DEXA)'}, {'measure': 'Bone Mineral Density (Total Hip)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'bone mineral density (total hip) evaluated trough dual-energy x-ray absorptiometry (DEXA)'}, {'measure': 'Bone Mineral Density (Lumbar Spine)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'bone mineral density (lumbar spine) evaluated trough dual-energy x-ray absorptiometry (DEXA)'}, {'measure': 'Bone Microarchitecture (Total Volumetric Density)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Bone microarchitecture (total volumetric density) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)'}, {'measure': 'Bone Microarchitecture (Trabecular Volumetric Density)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Bone microarchitecture (trabecular volumetric density) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)'}, {'measure': 'Bone Microarchitecture (Cortical Volumetric Density)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Bone microarchitecture (cortical volumetric density) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)'}, {'measure': 'Bone Microarchitecture (BV/TV)', 'timeFrame': '16 weeks', 'description': 'Bone microarchitecture (BV/TV) was assessed at the distal region of the radius of the non-dominant limb using high-resolution peripheral quantitative computed tomography (HR-pQCT). Specifically, trabecular bone volume fraction (BV/TV) is computed as the ratio of the trabecular bone mineral density (Tb.vBMD in mg HA/cm3) and 1200 mg HA/cm3, which is assumed to be the density of fully mineralized bone. Afterwards, the values were multiplied by 100 to reflect the percentage of trabecular bone volume fraction.'}, {'measure': 'Bone Microarchitecture (Trabecular Number - Tb. N)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'The trabecular number (Tb.N) was analyzed using the ridge extraction technique in high-resolution peripheral quantitative computed tomography (HR-pQCT). In this approach, the trabeculae were treated as elongated structures resembling ridges. The technique involves detecting the central axis (ridge) of each trabecular element in a 3D image.'}, {'measure': 'Bone Microarchitecture (Trabecular Separation)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Trabecular separation (Tb.Sp), represents the average distance between trabeculae in the trabecular bone region. It was assessed using the distance transformation method, applied to the background (void space) of the trabecular structure. The transformation method measures the distance from each voxel (3D pixel) in the void space to the nearest trabecular element, and the average of these distances is then calculated. This method enables precise quantification of trabecular spacing in high-resolution 3D images.\n\nThe separation is inversely related to trabecular density, as closer trabeculae indicate a higher bone volume fraction (BV/TV) and a denser bone network. The calculation of trabecular separation can be expressed as:\n\nTb.Sp = 1- BV/TV : Tb.N'}, {'measure': 'Bone Microarchitecture (Trabecular Thickness)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Trabecular thickness (Tb.Th) represents the average thickness of trabecular bone elements. It was assessed by calculating the mean thickness of the segmented trabecular structure, using the distance transformation method applied to the trabecular bone tissue.\n\nThe trabecular thickness is calculated as a ratio of the bone volume fraction (BV/TV) to trabecular number (Tb.N): Tb.Th =BV/TV : Tb.N'}, {'measure': 'Bone Microarchitecture (Cortical Porosity)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': "Cortical porosity (Ct.Po) is quantified using a density-based approach that segments bone into three compartments: compact cortex, transitional zone, and trabecular compartment. Voxels with a density below 1000 mg HA/cm³ indicate the presence of void space (pores), and porosity is estimated as the ratio of void space in each voxel. The mean of this ratio is calculated across all voxels in the compartment of interest, and the values were multiplied by 100. This method captures pores with diameters below the scanner's spatial resolution but relies on the assumption of fixed bone tissue mineral density and may be susceptible to image noise and beam hardening."}, {'measure': 'Bone Microarchitecture (Cortical Thickness)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Bone microarchitecture (cortical thickness) wwas assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)'}, {'measure': 'Bone Microarchitecture (Cortical Pore Diameter)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Bone microarchitecture (cortical pore diameter) was assessed at the distal region of the radius of the non-dominant limb using a high-resolution peripheral quantitative computed tomography (HR-pQCT)'}, {'measure': 'Bone Microarchitecture (Stiffness)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Stiffness (kN/mm) is defined as the total reaction force of the model divided by the applied displacement. It represents the resistance of a material or structure to deformation under an applied load. A higher stiffness value indicates greater resistance to deformation, while a lower value suggests more flexibility.'}, {'measure': 'Bone Microarchitecture (Estimated Failure Load)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Estimated failure load is indirectly calculated from linear finite element (FE) models using a yield criterion. The failure load is estimated when a specified volume of bone tissue (critical volume) exceeds a critical strain threshold, at which point the model is assumed to have yielded. This approach is often based on the Pistoia criterion, which is used to predict the point of failure in the material based on its mechanical properties and deformation behavior.'}, {'measure': 'Isometric Muscle Strength - Handgrip', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Isometric muscle strength was evaluated using a handgrip dynamometer (Jamar®, Sammons Preston Rolyan, USA).'}, {'measure': 'Muscle Strength - Upper Limbs', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Muscle strength was evaluated using maximal dynamic strength test \\[1RM\\])'}, {'measure': 'Muscle Strength - Lower Limbs', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Muscle strength was evaluated using maximal dynamic strength test \\[1RM\\])'}, {'measure': 'Muscle Function (Short Physical Performance Battery)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Muscle function evaluated through battery of tests - Short Physical Performance Battery (SPPB). The SPPB is a standardized assessment of lower extremity function that includes three components: balance tests, gait speed over 4 meters, and the five-times sit-to-stand test. Each component is scored from 0 to 4, with a total score ranging from 0 to 12. Higher scores indicate better physical performance. The SPPB is widely used to evaluate physical function, predict disability, and monitor health status in older adults.'}, {'measure': 'Muscle Function (30-s Sit-to-stand Test)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'The 30-second sit-to-stand test is a simple measure of lower body strength and functional capacity. Participants are asked to rise from a seated position and sit back down as many times as possible within 30 seconds. The total number of complete sit-to-stand repetitions performed in the given time is recorded. This test is commonly used to assess physical fitness and mobility, particularly in older adults or individuals with health conditions.'}, {'measure': 'Muscle Function (Timed-up-and-go)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'The Timed Up and Go (TUG) test is a simple and widely used assessment of mobility and balance. Participants are asked to stand up from a seated position, walk 3 meters, turn around, walk back to the chair, and sit down again, all as quickly as possible. The total time taken to complete the task is recorded. The TUG test is commonly used to evaluate functional mobility, fall risk, and the ability to perform daily activities, particularly in older adults or individuals with mobility impairments.'}, {'measure': 'Muscle Function (Gait Speed)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': "Muscle function evaluated through 4-m gait speed test. The 4-meter usual gait speed test measures the time it takes for a participant to walk a distance of 4 meters at their usual pace. The test is commonly used to assess walking speed, which is an important indicator of mobility, physical function, and overall health. The time taken to complete the 4-meter walk is recorded and used to evaluate the individual's functional capacity, with slower times potentially indicating mobility impairments or a higher risk of adverse health outcomes."}, {'measure': 'Cardiorespiratory Fitness', 'timeFrame': '16 weeks', 'description': 'Cardiorespiratory fitness was evaluated by maximal oxygen uptake (VO²max) during a maximal exercise test on a treadmill'}, {'measure': 'Insulin Sensitivity as Assessed by Surrogates of Insulin Sensitivity', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) is a method used to estimate insulin resistance based on fasting plasma glucose and fasting insulin levels. It is calculated using the following formula:\n\nHOMA-IR = (fasting insulin \\[µU/mL\\] × fasting glucose \\[mg/dL\\]) / 405. Higher values of HOMA-IR indicate greater insulin resistance and are considered worse. There is no fixed theoretical maximum value, but typical reference ranges in healthy individuals are usually \\<2. Values above this threshold may suggest impaired insulin sensitivity or metabolic dysfunction. The HOMA-IR is widely used in clinical and research settings as a surrogate marker for insulin resistance.'}, {'measure': 'Brachial Flow-mediated Dilation (FMD)', 'timeFrame': 'Baseline (Pre-intervention) and 16 weeks (Post-intervention)', 'description': 'Brachial flow-mediated dilation (FMD) is a non-invasive measure of endothelial function, assessed using high-resolution B-mode ultrasound. The test evaluates the percent change in brachial artery diameter in response to increased blood flow (reactive hyperemia) following 3 minutes of cuff occlusion, on the forearm. An increase in arterial diameter after cuff release indicates vasodilation mediated by nitric oxide. Higher FMD values reflect better endothelial function, whereas lower values are associated with cardiovascular risk and impaired vascular health.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcopenic Obesity', 'Aging']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate if protein supplementation increases the benefits of exercise training in the elderly with sarcopenic obesity undergoing caloric restriction.', 'detailedDescription': 'A major subset of adults over the age of 65 is now classified as having sarcopenic obesity, a high-risk geriatric syndrome predominantly observed in an aging population that is at risk of synergistic complications from both sarcopenia and obesity.\n\nLifestyle interventions such as caloric restriction and exercise training are effective nonpharmacological strategies to mitigate some adverse effects related to this condition. Also, protein supplementation may boost the benefits of exercise, but this assumption is still to be tested. This trial aims to test whether protein supplementation is able to increase the benefits of exercise training in the elderly with sarcopenic obesity undergoing caloric restriction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 65 years and older;\n* Body mass index (BMI) \\> 30 kg/m2;\n* Sarcopenia;\n* not engage into exercise training programas.\n\nExclusion Criteria:\n\n* cancer in the last 5 years;\n* cognitive deficit or dementia that impossibility the patient to read and sign the informed consent form;\n* any disease that limits participation in exercise training program.'}, 'identificationModule': {'nctId': 'NCT04981366', 'briefTitle': 'Protein Supplementation in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction and Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Effects of the Protein Supplementation Associated With Exercise Training in Elderly With Sarcopenic Obesity Undergoing Caloric Restriction', 'orgStudyIdInfo': {'id': '04234918.1.0000.0065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group (CTRL)', 'description': 'Patients allocated to this arm will not receive any intervention.'}, {'type': 'EXPERIMENTAL', 'label': 'Caloric Restriction associated to exercise training plus protein supplementation (CREX+PTN)', 'description': 'Patients allocated to this arm will be submitted to caloric restriction associated with exercise training program plus protein supplementation.', 'interventionNames': ['Dietary Supplement: Protein supplement']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Caloric Restriction associated to exercise training plus isocaloric placebo (CREX+PLA)', 'description': 'Patients allocated to this arm will be submitted to caloric restriction associated with exercise training program plus isocaloric placebo.', 'interventionNames': ['Dietary Supplement: isocaloric supplement']}], 'interventions': [{'name': 'Protein supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': '40g of whey protein in the breakfast;', 'armGroupLabels': ['Caloric Restriction associated to exercise training plus protein supplementation (CREX+PTN)']}, {'name': 'isocaloric supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': '42g of isocaloric supplement in the breakfast;', 'armGroupLabels': ['Caloric Restriction associated to exercise training plus isocaloric placebo (CREX+PLA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508-030', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Hamilton Roschel, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Hamilton Augusto Roschel da Silva', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}