Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-03 @ 3:00 PM
Study NCT ID:
NCT00473902
Status:
COMPLETED
Last Update Posted:
2007-05-16
First Post:
2007-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Older Adult Training Study With Creatine and CLA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003401', 'term': 'Creatine'}, {'id': 'D044243', 'term': 'Linoleic Acids, Conjugated'}], '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'}, {'id': 'D008041', 'term': 'Linoleic Acids'}, {'id': 'D043371', 'term': 'Fatty Acids, Omega-6'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-05', 'completionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-05-15', 'studyFirstSubmitDate': '2007-05-15', 'studyFirstSubmitQcDate': '2007-05-15', 'lastUpdatePostDateStruct': {'date': '2007-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'a. Muscle and bone mass b. Knee extension strength e. Creatine content f. Muscle oxidative capacity g. Aerobic power (oxygen consumption)', 'timeFrame': 'six months'}], 'secondaryOutcomes': [{'measure': 'a. Functional capacity b. Strength with weight machines', 'timeFrame': 'six months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '17912368', 'type': 'DERIVED', 'citation': 'Tarnopolsky M, Zimmer A, Paikin J, Safdar A, Aboud A, Pearce E, Roy B, Doherty T. Creatine monohydrate and conjugated linoleic acid improve strength and body composition following resistance exercise in older adults. PLoS One. 2007 Oct 3;2(10):e991. doi: 10.1371/journal.pone.0000991.'}]}, 'descriptionModule': {'briefSummary': 'We examined whether creatine monohydrate (CrM) and conjugated linoleic acid (CLA) could enhance strength gains and improve body composition (i.e., increase fat-free mass (FFM); decrease body fat) following resistance exercise training in older adults (\\> 65 y). Our study hypothesized that administering CrM and CLA would yield greater strength and body composition benefits than the placebo group over the six months of resistance exercise', 'detailedDescription': 'Men (N=19) and women (N=20) completed six months of resistance exercise training with Creatine Monohydrate (5g/d) + Conjugated Linoleic Acid (6g/d) or placebo with randomized, double-blind, allocation.Outcomes included; strength and muscular endurance, functional tasks, body composition (DEXA scan), blood tests (lipids, liver function, CK, glucose, systemic inflammation markers (IL-6, C-reactive protein)), urinary markers of compliance (creatine/creatinine), oxidative stress (8-OH-2dG, 8-isoP) and bone resorption (Ν-telopeptides).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy,\n* Ambulatory,\n* Recreationally active,\n* Community dwelling\n\nExclusion Criteria:\n\n* Evidence of coronary heart disease;\n* Congestive heart disease;\n* Uncontrolled hypertension;\n* Chronic obstructive pulmonary disease;\n* Diabetes mellitus;\n* Renal failure;\n* Major orthopedic disability; and\n* Smoking'}, 'identificationModule': {'nctId': 'NCT00473902', 'acronym': 'OTR', 'briefTitle': 'Older Adult Training Study With Creatine and CLA', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Creatine Monohydrate and Conjugated Linoleic Acid Improve Strength and Body Composition Following Resistance Exercise in Older Adults', 'orgStudyIdInfo': {'id': 'Older Adult Training Study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Training', 'type': 'BEHAVIORAL'}, {'name': 'Creatine Monohydrate, Conjugated Linoleic Acid', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University Medical Center', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Mark A Tarnopolsky, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}}}}