Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-27 @ 1:22 AM
Study NCT ID:
NCT05287659
Status:
COMPLETED
Last Update Posted:
2022-03-18
First Post:
2022-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Calorie Diet or VLCKD Combined With Physical Training for Preserving Muscle Mass During Weight Loss in Sarcopenic Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D007930', 'term': 'Leucine'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-16', 'studyFirstSubmitDate': '2022-03-04', 'studyFirstSubmitQcDate': '2022-03-16', 'lastUpdatePostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight', 'timeFrame': 'Body weight will be calculated at baseline and after 45 days', 'description': 'Body weight change from baseline'}], 'secondaryOutcomes': [{'measure': 'Body Mass Index', 'timeFrame': 'Body Mass Index will be calculated at baseline and after 45 days', 'description': 'Body Mass Index change from baseline'}, {'measure': 'Fat Mass', 'timeFrame': 'Fat Mass will be calculated at baseline and after 45 days', 'description': 'Fat mass percentage (%) change from baseline'}, {'measure': 'Fat Free Mass', 'timeFrame': 'Fat Free mass will be calculated at baseline and after 45 days', 'description': 'Fat Free mass percentage (%) change from baseline'}, {'measure': 'Fasting glucose', 'timeFrame': 'Fasting glucose will be calculated at baseline and after 45 days', 'description': 'Fasting glucose level (mg/dL) change from baseline'}, {'measure': 'Fasting insulin', 'timeFrame': 'Fasting insulin will be calculated at baseline and after 45 days', 'description': 'Fasting Insulin level (mcU/mL) change from baseline'}, {'measure': 'Muscle strength', 'timeFrame': 'Muscle strength will be calculated at baseline and after 45 days', 'description': 'Muscle strength (kg) change from baseline'}, {'measure': 'Physical Performance assessed by Short Physical Performance Battery (SPPB)', 'timeFrame': 'SPPB will be calculated at baseline and after 45 days', 'description': 'Physical Performance change from baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcopenic Obesity']}, 'descriptionModule': {'briefSummary': 'The prevalence of sarcopenic obesity (SO) is increasing worldwide, posing important challenges to public health and national health care system, especially during the COVID pandemic. In subjects with SO, it is essential to reduce body weight preserving lean mass, in order to avoid a worsening of muscle function. Lifestyle modification with adequate nutrition and proper physical activity is essential to counteract SO progression. In accordance with the Position Statement of the Italian Society of Endocrinology, Very Low Calorie Ketogenic Diet (VLCKD), a well established nutritional intervention in the context of obesity, has been promoted also for the treatment of SO. Moreover, the source of protein, timing of intake, and specific amino-acid constitution also represent critical factors in increasing muscle mass and strength. Recent studies have shown how protein supplementation, especially with high leucine content, can be effective in degenerative and end-stage diseases.\n\nTo date, the effects of physical training during VLCKD have not been studied. The aim is to determine the efficacy of VLCKD combined with interval training, compared to a VLCKD or a LCD alone, on weight-loss, body composition and physical performance in patient with SO.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obesity (BMI 30-40)\n* FAT MASS % ( \\> 41% for W, \\>29% for M)\n* HOMA-IR \\> 2,5\n\nExclusion Criteria:\n\n* known hypersensitivity to one or more components used in the protocol products; history of renal, cardiac or cerebrovascular diseases; psychiatric disturbances; hydroelectrolytic alterations, diagnosis of type 1 diabetes lack of informed consent; history of or planned weight loss surgery'}, 'identificationModule': {'nctId': 'NCT05287659', 'briefTitle': 'Low Calorie Diet or VLCKD Combined With Physical Training for Preserving Muscle Mass During Weight Loss in Sarcopenic Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Low Calorie Diet or Very Low Calorie Ketogenic Diet Combined With Physical Training for Preserving Muscle Mass During Weight Loss in Sarcopenic Obesity', 'orgStudyIdInfo': {'id': 'DM2022SO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VLCKD group', 'description': 'patients followed a structured VLCKD protocol (800Kcal/die)', 'interventionNames': ['Dietary Supplement: meal replacements or supplementation with leucine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VLCKD and Physical Training group', 'description': 'patients followed a structured VLCKD protocol (800Kcal/die) combined with interval training (IT), two times a week', 'interventionNames': ['Dietary Supplement: meal replacements or supplementation with leucine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LCD and Leucine supplementation group', 'description': 'patients followed a LCD regimen (1000 kcal/day) with supplementation of 18 g whey proteins which 4.1 g of leucine', 'interventionNames': ['Dietary Supplement: meal replacements or supplementation with leucine']}], 'interventions': [{'name': 'meal replacements or supplementation with leucine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'meal replacements or animal protein or supplementation with leucine', 'armGroupLabels': ['LCD and Leucine supplementation group', 'VLCKD and Physical Training group', 'VLCKD group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00161', 'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'facility': 'Sapienza University of Rome', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lucio Gnessi', 'investigatorFullName': 'Lucio Gnessi', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}