Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT01305018
Status:
SUSPENDED
Last Update Posted:
2011-05-05
First Post:
2011-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Branched-chain Amino Acids Supplementation and Resistance Exercise-induced Muscle Damage and Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007930', 'term': 'Leucine'}], '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-05-04', 'studyFirstSubmitDate': '2011-02-25', 'studyFirstSubmitQcDate': '2011-02-25', 'lastUpdatePostDateStruct': {'date': '2011-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle maximal strength', 'timeFrame': '4 days'}, {'measure': 'Muscle edema', 'timeFrame': '4 days'}, {'measure': 'Muscle soreness', 'timeFrame': '4 days'}], 'secondaryOutcomes': [{'measure': 'Muscle inflammation', 'timeFrame': '4 days', 'description': 'Immunohistochemistry, protein expression.'}, {'measure': 'Muscle damage', 'timeFrame': '4 days', 'description': 'Serum creatine kinase'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Branched-chain amino acids', 'Leucine', 'Muscle damage', 'Inflammation', 'supplementation', 'resistance exercise-induced'], 'conditions': ['Muscle Damage', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effects of branched-chain amino acids (BCAA) supplementation on resistance exercise-induced muscle damage and inflammation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sedentary;\n* No muscle disorders;\n* Must be able to swallow tablets'}, 'identificationModule': {'nctId': 'NCT01305018', 'briefTitle': 'Branched-chain Amino Acids Supplementation and Resistance Exercise-induced Muscle Damage and Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Effects of Leucine and Branched-chain Amino Acids (BCAA) Supplementation on Resistance Exercise-induced Muscle Damage and Inflammation: a Randomized, Double-blind, and Placebo-controlled Study', 'orgStudyIdInfo': {'id': '071287'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise and BCAA', 'interventionNames': ['Dietary Supplement: BCAA']}, {'type': 'EXPERIMENTAL', 'label': 'Exercise and Leucine', 'interventionNames': ['Dietary Supplement: Leucine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Exercise and Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'BCAA', 'type': 'DIETARY_SUPPLEMENT', 'description': '7 g of leucine + 3,5 g of isoleucine + 3,5 g of valine per day during 9 days', 'armGroupLabels': ['Exercise and BCAA']}, {'name': 'Leucine', 'type': 'DIETARY_SUPPLEMENT', 'description': '7 g of leucine + 7 g of alanine per day during 9 days', 'armGroupLabels': ['Exercise and Leucine']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '14 g of alanine per day during 9 days', 'armGroupLabels': ['Exercise and Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508-030', '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}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Claudia Ribeiro da Luz', 'oldOrganization': 'University of São Paulo'}}}}