Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT02519751
Status:
COMPLETED
Last Update Posted:
2015-08-11
First Post:
2015-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Method Using Deuterium Labelled Creatine to Measure Total Body Skeletal Muscle Mass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003401', 'term': 'Creatine'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-06', 'studyFirstSubmitDate': '2015-07-23', 'studyFirstSubmitQcDate': '2015-08-06', 'lastUpdatePostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between muscle mass obtained by MRI method and D3-Creatine method', 'timeFrame': 'Upto 3 months', 'description': 'MRI scan of the participants will be done at Day 1 and end of study (i.e.Day 90).D3-Creatine capsule will be given orally at Day 1 and urine samples collected at 0-4h and 4-24h every day from Day 1 to Day 4.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sports Nutritional Sciences']}, 'descriptionModule': {'briefSummary': 'Creatine (methyl-d3) dilution (D3-creatine) is a novel technique for the estimation of muscle mass. The method uses a dose of deuterium-labelled creatine to determine total skeletal muscle mass via estimation of total body creatine pool size.The aim of this study is to compare estimates of total body skeletal muscle mass by D3-creatine dilution method and whole body Magnetic Resonance Imaging (MRI) in an athletic population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Trained and competing elite canoe athletes will be recruited, who represent Great Britain Canoeing\n\nExclusion Criteria:\n\n* Pregnant and lactating women\n* Intolerance or hypersensitivity to Creatine supplementation\n* Athletes with disabilities which affect their total body muscle mass\n* If creatine was taken in a supplemented form, rather than dietary intake, more regularly than once a week within 6-weeks of assessment commencing\n* Contraindication to an MRI scan'}, 'identificationModule': {'nctId': 'NCT02519751', 'briefTitle': 'New Method Using Deuterium Labelled Creatine to Measure Total Body Skeletal Muscle Mass', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Total Body Skeletal Muscle Mass Estimation by Creatine (Methyl-d3) Dilution in Athletes', 'orgStudyIdInfo': {'id': '202600'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'D3 Creatine followed by creatine supplementation', 'description': 'Every participant will be orally administered with 60mg of D3 Creatine in a fasted state in a non-gelatin capsule. Creatine supplemented throughout the study will be administered in the following doses-0.03, 0.035, 0.04, 0.045 g.kg.Lean mass/day, increasing on weekly basis. Final dose of 0.05 g.kg.Lean mass/day is then maintained throughout the study.', 'interventionNames': ['Dietary Supplement: D3 Creatine', 'Dietary Supplement: Creatine']}], 'interventions': [{'name': 'D3 Creatine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One dose of D3 Creatine (60mg capsule) given orally on Day 1', 'armGroupLabels': ['D3 Creatine followed by creatine supplementation']}, {'name': 'Creatine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will consume an individual dosed level of creatine, based on their estimated muscle mass in doses of 0.03, 0.035, 0.04, 0.045 g.kg.Lean mass/day, increasing on a weekly basis. Final dose of 0.05 g.kg.Lean mass/day is then maintained throughout the study.', 'armGroupLabels': ['D3 Creatine followed by creatine supplementation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'TW8 9 DA', 'city': 'Brentford', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.48619, 'lon': -0.3083}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}