Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-28 @ 4:43 PM
Study NCT ID:
NCT01496768
Status:
SUSPENDED
Last Update Posted:
2013-02-25
First Post:
2011-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Chronic Leucine Supplemetion on Glucose Homeostasis, Body Compositin, Muscle Mass and Strength of Healthy and Young Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007930', 'term': 'Leucine'}, {'id': 'D000409', 'term': 'Alanine'}], 'ancestors': [{'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-22', 'studyFirstSubmitDate': '2011-12-19', 'studyFirstSubmitQcDate': '2011-12-19', 'lastUpdatePostDateStruct': {'date': '2013-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle strenght', 'timeFrame': '3 months'}, {'measure': 'Body composition', 'timeFrame': '3 months'}, {'measure': 'Muscle cross-sectional area', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Glucose homeostasis', 'timeFrame': '3 months'}, {'measure': 'Lipid profile', 'timeFrame': '3 months'}, {'measure': 'Systemic inflammation', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Effect of Chronic Leucine Supplementation on Glucose Homeostasis, Lipid Profile, Body Composition, and Muscle Mass and Strenght']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effects of chronic leucine supplemetion on glucose homeostasis, body compositin, muscle mass and strength of healthy and young subjects'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-smokers;\n* Healthy;\n* Non-users of dietary supplements and drugs\n* Not engaged in any regular physical activity program\n\nExclusion Criteria:\n\n* Vegetarians'}, 'identificationModule': {'nctId': 'NCT01496768', 'briefTitle': 'Effects of Chronic Leucine Supplemetion on Glucose Homeostasis, Body Compositin, Muscle Mass and Strength of Healthy and Young Subjects', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effects of Chronic Leucine Supplemetion on Glucose Homeostasis, Body Compositin, Muscle Mass and Strength of Healthy and Young Subjects: a Randomized, Double-blind, and Placebo Controlled Trial', 'orgStudyIdInfo': {'id': '20120412'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Leucine', 'interventionNames': ['Dietary Supplement: Leucine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Alanine', 'interventionNames': ['Dietary Supplement: Alanine']}], 'interventions': [{'name': 'Leucine', 'type': 'DIETARY_SUPPLEMENT', 'description': '7,2 g/day during 3 months', 'armGroupLabels': ['Leucine']}, {'name': 'Alanine', 'type': 'DIETARY_SUPPLEMENT', 'description': '7,2 g/day during 3 months', 'armGroupLabels': ['Alanine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508030', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University of São Paulo - School of Physical Education and Sports', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Kerolyn de Souza Valente', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'Humberto Nicastro', 'investigatorAffiliation': 'University of Sao Paulo'}}}}