Ignite Creation Date:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2026-03-03 @ 2:26 PM
Study NCT ID:
NCT03350906
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2017-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Enhancing Adaptations to Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D015502', 'term': 'Absorptiometry, Photon'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}], 'ancestors': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Lanza.Ian@mayo.edu', 'phone': '507-255-8147', 'title': 'Ian R. Lanza, Ph.D.', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from baseline to end of study, approximately 8 months', 'eventGroups': [{'id': 'EG000', 'title': 'n3-PUFA (Docosahexaenoic Acid (DHA)/EPA)', 'description': "Participants swallowed 2 Docosahexaenoic acid (DHA)/EPA soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.\n\nn3-PUFA: The DHA/EPA softgels contained \\~465mg of EPA and \\~375mg of DHA for a total daily dosage of 3.4g/day. Additionally, each capsule contained SCI's proprietary Advance Lipid TechnologiesTM (ALTTM) containing the surfactants polysorbate 80, NF (\\~381 mg) and poloxamer 237, NF (\\~8.8 mg).\n\nBiopsy: Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision was made through the skin, and a needle was used to remove the muscle.", 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants swallowed 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.\n\nPlacebo: Looks exactly like the study drug but contained soybean oil with no active ingredient.\n\nBiopsy: Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision was made through the skin, and a needle was used to remove the muscle.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Maximum Workload Muscle Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'n3-PUFA (Docosahexaenoic Acid (DHA)/EPA)', 'description': "Participants swallowed 2 Docosahexaenoic acid (DHA)/EPA soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.\n\nn3-PUFA: The DHA/EPA softgels contained \\~465mg of EPA and \\~375mg of DHA for a total daily dosage of 3.4g/day. Additionally, each capsule contained SCI's proprietary Advance Lipid TechnologiesTM (ALTTM) containing the surfactants polysorbate 80, NF (\\~381 mg) and poloxamer 237, NF (\\~8.8 mg).\n\nBiopsy: Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision was made through the skin, and a needle was used to remove the muscle.\n\nBody Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants swallowed 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.\n\nPlacebo: Looks exactly like the study drug but contained soybean oil with no active ingredient.\n\nBiopsy: Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision was made through the skin, and a needle was used to remove the muscle.\n\nBody Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '14.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': 'Single-leg knee extensor strength was measured on a pneumatic resistance leg extension machine (Keiser Air300, Keiser Corporation, Fresno, CA, USA) and defined as the unilateral 1-repetition maximum (1-RM). Subjects performed a unilateral knee extension warm-up consisting of 10 repetitions at minimal resistance and 3 sets of 5-10 repetitions at increasing workloads. Subjects then performed a series of single repetition attempts at increasing workloads, each separated by 3 min of rest, until the maximum load that could be moved through the entire range of motion was reached. This maximum workload was defined as the individual 1-RM.', 'unitOfMeasure': 'pounds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'n3-PUFA (Docosahexaenoic Acid (DHA)/EPA)', 'description': "Participants swallowed 2 Docosahexaenoic acid (DHA)/EPA soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.\n\nn3-PUFA: The DHA/EPA softgels contained \\~465mg of EPA and \\~375mg of DHA for a total daily dosage of 3.4g/day. Additionally, each capsule contained SCI's proprietary Advance Lipid TechnologiesTM (ALTTM) containing the surfactants polysorbate 80, NF (\\~381 mg) and poloxamer 237, NF (\\~8.8 mg).\n\nBiopsy: Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision was made through the skin, and a needle was used to remove the muscle.\n\nBody Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants swallowed 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.\n\nPlacebo: Looks exactly like the study drug but contained soybean oil with no active ingredient.\n\nBiopsy: Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision was made through the skin, and a needle was used to remove the muscle.\n\nBody Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '27.1', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '26.3', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '27.2', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '26.3', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': "Subject's BMI calculated as weight in kilograms divided by height in meters squared. Uses measurements of height and weight obtained during study (with appropriate metric conversions). Measured as kg/m\\^2", 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Body Fat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'n3-PUFA (Docosahexaenoic Acid (DHA)/EPA)', 'description': "Participants swallowed 2 Docosahexaenoic acid (DHA)/EPA soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.\n\nn3-PUFA: The DHA/EPA softgels contained \\~465mg of EPA and \\~375mg of DHA for a total daily dosage of 3.4g/day. Additionally, each capsule contained SCI's proprietary Advance Lipid TechnologiesTM (ALTTM) containing the surfactants polysorbate 80, NF (\\~381 mg) and poloxamer 237, NF (\\~8.8 mg).\n\nBiopsy: Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision was made through the skin, and a needle was used to remove the muscle.\n\nBody Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants swallowed 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.\n\nPlacebo: Looks exactly like the study drug but contained soybean oil with no active ingredient.\n\nBiopsy: Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision was made through the skin, and a needle was used to remove the muscle.\n\nBody Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '36.9', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '35.8', 'spread': '8.9', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '36.7', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '35.8', 'spread': '9.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': 'Dexa Scan based body fat, measured as a percentage of body weight', 'unitOfMeasure': 'percentage of body weight', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Lean Body Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'n3-PUFA (Docosahexaenoic Acid (DHA)/EPA)', 'description': "Participants swallowed 2 Docosahexaenoic acid (DHA)/EPA soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.\n\nn3-PUFA: The DHA/EPA softgels contained \\~465mg of EPA and \\~375mg of DHA for a total daily dosage of 3.4g/day. Additionally, each capsule contained SCI's proprietary Advance Lipid TechnologiesTM (ALTTM) containing the surfactants polysorbate 80, NF (\\~381 mg) and poloxamer 237, NF (\\~8.8 mg).\n\nBiopsy: Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision was made through the skin, and a needle was used to remove the muscle.\n\nBody Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants swallowed 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.\n\nPlacebo: Looks exactly like the study drug but contained soybean oil with no active ingredient.\n\nBiopsy: Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision was made through the skin, and a needle was used to remove the muscle.\n\nBody Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '46.0', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '45.5', 'spread': '10.6', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '46.1', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '45.5', 'spread': '10.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': 'Lean body mass as measured by a DEXA scan is the amount of soft tissue that is not fat or bone. Measured in kilograms.', 'unitOfMeasure': 'kilograms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'C-Reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'n3-PUFA (Docosahexaenoic Acid (DHA)/EPA)', 'description': "Participants swallowed 2 Docosahexaenoic acid (DHA)/EPA soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.\n\nn3-PUFA: The DHA/EPA softgels contained \\~465mg of EPA and \\~375mg of DHA for a total daily dosage of 3.4g/day. Additionally, each capsule contained SCI's proprietary Advance Lipid TechnologiesTM (ALTTM) containing the surfactants polysorbate 80, NF (\\~381 mg) and poloxamer 237, NF (\\~8.8 mg).\n\nBiopsy: Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision was made through the skin, and a needle was used to remove the muscle.\n\nBody Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants swallowed 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.\n\nPlacebo: Looks exactly like the study drug but contained soybean oil with no active ingredient.\n\nBiopsy: Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision was made through the skin, and a needle was used to remove the muscle.\n\nBody Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': 'C-reactive protein is a substance produced by the liver in response to inflammation. Normal CRP levels are below 3.0 mg/L.Units: mg/L', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Erythrocyte Sedimentation Rate (ESR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'n3-PUFA (Docosahexaenoic Acid (DHA)/EPA)', 'description': "Participants swallowed 2 Docosahexaenoic acid (DHA)/EPA soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.\n\nn3-PUFA: The DHA/EPA softgels contained \\~465mg of EPA and \\~375mg of DHA for a total daily dosage of 3.4g/day. Additionally, each capsule contained SCI's proprietary Advance Lipid TechnologiesTM (ALTTM) containing the surfactants polysorbate 80, NF (\\~381 mg) and poloxamer 237, NF (\\~8.8 mg).\n\nBiopsy: Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision was made through the skin, and a needle was used to remove the muscle.\n\nBody Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants swallowed 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.\n\nPlacebo: Looks exactly like the study drug but contained soybean oil with no active ingredient.\n\nBiopsy: Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision was made through the skin, and a needle was used to remove the muscle.\n\nBody Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.8', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '7.5', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '9.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': 'ESR is a blood test that can reveal inflammatory activity in the body. It measures the distance red blood cells fall in a test tube in one hour. The farther the red blood cells have descended, the greater the inflammatory response of the immune system. Normal results: \\< 16 years: \\< 10 mm/hr;Male \\< 50 years: \\< 15 mm/hr;Male \\> 50 years: \\< 20 mm/hr;Female \\< 50 years: \\< 20 mm/hr;Female \\> 50 years: \\< 30 mm/hr', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'n3-PUFA (Docosahexaenoic Acid (DHA)/EPA)', 'description': "Participants swallowed 2 Docosahexaenoic acid (DHA)/EPA soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.\n\nn3-PUFA: The DHA/EPA softgels contained \\~465mg of EPA and \\~375mg of DHA for a total daily dosage of 3.4g/day. Additionally, each capsule contained SCI's proprietary Advance Lipid TechnologiesTM (ALTTM) containing the surfactants polysorbate 80, NF (\\~381 mg) and poloxamer 237, NF (\\~8.8 mg).\n\nBiopsy: Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision was made through the skin, and a needle was used to remove the muscle.\n\nBody Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat."}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants swallowed 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.\n\nPlacebo: Looks exactly like the study drug but contained soybean oil with no active ingredient.\n\nBiopsy: Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision was made through the skin, and a needle was used to remove the muscle.\n\nBody Composition Scan: Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '77.3', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '74.5', 'spread': '14.5', 'groupId': 'OG001'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '77.1', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '74.5', 'spread': '14.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 months', 'description': 'Subjects calculated weight in kilograms', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'n3-PUFA (Docosahexaenoic Acid (DHA)/EPA)', 'description': "Participants swallowed 2 Docosahexaenoic acid (DHA)/EPA soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.\n\nn3-PUFA: The DHA/EPA softgels contained \\~465mg of EPA and \\~375mg of DHA for a total daily dosage of 3.4g/day. Additionally, each capsule contained SCI's proprietary Advance Lipid TechnologiesTM (ALTTM) containing the surfactants polysorbate 80, NF (\\~381 mg) and poloxamer 237, NF (\\~8.8 mg).\n\nBiopsy: Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision was made through the skin, and a needle was used to remove the muscle."}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants swallowed 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.\n\nPlacebo: Looks exactly like the study drug but contained soybean oil with no active ingredient.\n\nBiopsy: Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision was made through the skin, and a needle was used to remove the muscle.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'n3-PUFA (Docosahexaenoic Acid (DHA)/EPA)', 'description': "Participants swallowed 2 Docosahexaenoic acid (DHA)/EPA soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.\n\nn3-PUFA: The DHA/EPA softgels contained \\~465mg of EPA and \\~375mg of DHA for a total daily dosage of 3.4g/day. Additionally, each capsule contained SCI's proprietary Advance Lipid TechnologiesTM (ALTTM) containing the surfactants polysorbate 80, NF (\\~381 mg) and poloxamer 237, NF (\\~8.8 mg).\n\nBiopsy: Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision was made through the skin, and a needle was used to remove the muscle."}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants swallowed 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.\n\nPlacebo: Looks exactly like the study drug but contained soybean oil with no active ingredient.\n\nBiopsy: Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision was made through the skin, and a needle was used to remove the muscle.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '71.4', 'spread': '4.5', 'groupId': 'BG000'}, {'value': '71.5', 'spread': '4.8', 'groupId': 'BG001'}, {'value': '71.45', 'spread': '4.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], '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'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-25', 'size': 309926, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-09-20T14:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'dispFirstSubmitDate': '2022-11-07', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-23', 'studyFirstSubmitDate': '2017-11-13', 'resultsFirstSubmitDate': '2023-09-28', 'studyFirstSubmitQcDate': '2017-11-17', 'dispFirstPostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-23', 'studyFirstPostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Maximum Workload Muscle Strength', 'timeFrame': 'baseline, 6 months', 'description': 'Single-leg knee extensor strength was measured on a pneumatic resistance leg extension machine (Keiser Air300, Keiser Corporation, Fresno, CA, USA) and defined as the unilateral 1-repetition maximum (1-RM). Subjects performed a unilateral knee extension warm-up consisting of 10 repetitions at minimal resistance and 3 sets of 5-10 repetitions at increasing workloads. Subjects then performed a series of single repetition attempts at increasing workloads, each separated by 3 min of rest, until the maximum load that could be moved through the entire range of motion was reached. This maximum workload was defined as the individual 1-RM.'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'baseline, 6 months', 'description': "Subject's BMI calculated as weight in kilograms divided by height in meters squared. Uses measurements of height and weight obtained during study (with appropriate metric conversions). Measured as kg/m\\^2"}, {'measure': 'Body Fat', 'timeFrame': 'baseline, 6 months', 'description': 'Dexa Scan based body fat, measured as a percentage of body weight'}, {'measure': 'Lean Body Mass', 'timeFrame': 'baseline, 6 months', 'description': 'Lean body mass as measured by a DEXA scan is the amount of soft tissue that is not fat or bone. Measured in kilograms.'}], 'secondaryOutcomes': [{'measure': 'C-Reactive Protein (CRP)', 'timeFrame': 'baseline, 6 months', 'description': 'C-reactive protein is a substance produced by the liver in response to inflammation. Normal CRP levels are below 3.0 mg/L.Units: mg/L'}, {'measure': 'Erythrocyte Sedimentation Rate (ESR)', 'timeFrame': 'baseline, 6 months', 'description': 'ESR is a blood test that can reveal inflammatory activity in the body. It measures the distance red blood cells fall in a test tube in one hour. The farther the red blood cells have descended, the greater the inflammatory response of the immune system. Normal results: \\< 16 years: \\< 10 mm/hr;Male \\< 50 years: \\< 15 mm/hr;Male \\> 50 years: \\< 20 mm/hr;Female \\< 50 years: \\< 20 mm/hr;Female \\> 50 years: \\< 30 mm/hr'}, {'measure': 'Weight', 'timeFrame': 'baseline, 6 months', 'description': 'Subjects calculated weight in kilograms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'muscle function'], 'conditions': ['Inflammation']}, 'referencesModule': {'references': [{'pmid': '38547208', 'type': 'DERIVED', 'citation': 'Moosavi D, Vuckovic I, Kunz HE, Lanza IR. Metabolomic response to acute resistance exercise in healthy older adults by 1H-NMR. PLoS One. 2024 Mar 28;19(3):e0301037. doi: 10.1371/journal.pone.0301037. eCollection 2024.'}, {'pmid': '35389487', 'type': 'DERIVED', 'citation': 'Moosavi D, Vuckovic I, Kunz HE, Lanza IR. A Randomized Trial of omega-3 Fatty Acid Supplementation and Circulating Lipoprotein Subclasses in Healthy Older Adults. J Nutr. 2022 Jul 6;152(7):1675-1689. doi: 10.1093/jn/nxac084.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are trying to understand how chronic inflammation affects muscle function and responses to exercise.They are also trying to determine if suppressing chronic inflammation using omega-3 fatty acids (n3-PUFA) restores skeletal muscle function and exercise responsiveness in older adults.', 'detailedDescription': 'Participants will be divided into two groups. Men and women between the ages of 20-35 years and 65-85 years. Participants in the older age group will be randomly assigned to receive groups (n3-PUFA or placebo (soybean oil)) in a double-blind manner. Before and after the intervention, all participants will complete an outpatient study day (body composition, blood draw, treadmill test, strength test) and an inpatient study day (muscle biopsies, fat biopsies, indirect calorimetry, exercise test, mixed meal test). During the intervention phase of the study, participants will be instructed to swallow 2 softgels twice per day with meals (morning and evening) for a total of 4 softgels per day. Every 4 weeks, participants will report to the Clinical Research and Trials Unit (CRTU) to pick up a new prescription and return any remaining capsules from the previous prescription. On the day they pick up prescription refills, participants will report to the CRTU for a fasting blood sample. The duration of the intervention will be 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Men and women between the ages of 20-35 years\n* Men and women between the ages of 65-85 years\n\nExclusion criteria:\n\n* Regular use of omega-3 nutritional supplements\n* Diabetes or fasting plasma glucose \\> or equal to 126 mg/dL\n* Anemia (female subjects hemoglobin of \\<11 g/dl and male subjects hemoglobin \\<12 g/dl)\n* Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment)\n* Renal failure (serum creatinine \\> 1.5mg/dl)\n* Chronic active liver disease (AST\\>144 IU/L or ALT\\>165 IU/L)\n* Oral warfarin group medications or history of blood clotting disorders.\n* international normalized ratio (INR) \\>2.01.5\n* Smoking\n* Pregnancy or breastfeeding\n* Alcohol consumption greater than 2 glasses/day or other substance abuse\n* Untreated or uncontrolled hypothyroidism\n* Debilitating chronic disease (at the discretion of the investigators)\n* Fish or shellfish allergy'}, 'identificationModule': {'nctId': 'NCT03350906', 'briefTitle': 'Enhancing Adaptations to Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Enhancing Adaptations to Exercise', 'orgStudyIdInfo': {'id': '17-004403'}, 'secondaryIdInfos': [{'id': 'R01AG054454', 'link': 'https://reporter.nih.gov/quickSearch/R01AG054454', 'type': 'NIH'}, {'id': 'UL1RR024150', 'link': 'https://reporter.nih.gov/quickSearch/UL1RR024150', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'n3-PUFA', 'description': 'Participants will be instructed to swallow 2 Docosahexaenoic acid (DHA)/EPA soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.', 'interventionNames': ['Drug: n3-PUFA', 'Procedure: Biopsy', 'Diagnostic Test: Body Composition Scan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will be instructed to swallow 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.', 'interventionNames': ['Drug: Placebo', 'Procedure: Biopsy', 'Diagnostic Test: Body Composition Scan']}], 'interventions': [{'name': 'n3-PUFA', 'type': 'DRUG', 'description': "The DHA/EPA softgels will each contain \\~465mg of EPA and \\~375mg of DHA for a total daily dosage of 3.4g/day. Additionally, each capsule will contain SCI's proprietary Advance Lipid TechnologiesTM (ALTTM) containing the surfactants polysorbate 80, NF (\\~381 mg) and poloxamer 237, NF (\\~8.8 mg).", 'armGroupLabels': ['n3-PUFA']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Looks exactly like the study drug but contains soybean oil with no active ingredient.', 'armGroupLabels': ['Placebo']}, {'name': 'Biopsy', 'type': 'PROCEDURE', 'description': 'Two muscle biopsies from the upper part of one leg. A small (\\~1cm) incision will be made through the skin, and a needle will then be used to remove the muscle.', 'armGroupLabels': ['Placebo', 'n3-PUFA']}, {'name': 'Body Composition Scan', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['DEXA (dual-energy X-ray absorptiometry) scan.'], 'description': 'Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.', 'armGroupLabels': ['Placebo', 'n3-PUFA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Ian R Lanza, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Medicine', 'investigatorFullName': 'Ian R. Lanza', 'investigatorAffiliation': 'Mayo Clinic'}}}}