Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT01164020
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2010-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Creatine Supplementation and Cognition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003401', 'term': 'Creatine'}, {'id': 'D005947', 'term': 'Glucose'}, {'id': 'D055070', 'term': 'Resistance Training'}], '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': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-17', 'studyFirstSubmitDate': '2010-07-15', 'studyFirstSubmitQcDate': '2010-07-15', 'lastUpdatePostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cognitive function', 'timeFrame': 'six months'}], 'secondaryOutcomes': [{'measure': 'physical capacity', 'timeFrame': 'six months', 'description': 'muscle strength and function'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cognition', 'supplementation creatine', 'resistance training', 'aging'], 'conditions': ['Cognition', 'Aging']}, 'referencesModule': {'references': [{'pmid': '24098469', 'type': 'DERIVED', 'citation': 'Alves CR, Merege Filho CA, Benatti FB, Brucki S, Pereira RM, de Sa Pinto AL, Lima FR, Roschel H, Gualano B. Creatine supplementation associated or not with strength training upon emotional and cognitive measures in older women: a randomized double-blind study. PLoS One. 2013 Oct 3;8(10):e76301. doi: 10.1371/journal.pone.0076301. eCollection 2013.'}]}, 'descriptionModule': {'briefSummary': 'Resistance training as well as creatine supplementation may be beneficial for cognitive function, such as memory and attention. Therefore, the investigators speculate that resistance training combined with creatine supplementation would promote additive benefits on cognitive function in elderly women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women older than 60 years old\n\nExclusion Criteria:\n\n* cardiovascular diseases or muscular disturbances precluding exercise training\n* drugs affecting the cognition'}, 'identificationModule': {'nctId': 'NCT01164020', 'briefTitle': 'Creatine Supplementation and Cognition', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'orgStudyIdInfo': {'id': 'Creatine and Cognition'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo control', 'description': 'this only receives placebo (dextrose)', 'interventionNames': ['Other: Placebo (Dextrose)']}, {'type': 'EXPERIMENTAL', 'label': 'placebo and exercise', 'description': 'this is trained and receives placebo', 'interventionNames': ['Other: Placebo (Dextrose)', 'Other: Resistance training']}, {'type': 'EXPERIMENTAL', 'label': 'creatine supplementation', 'description': 'this is non-exercise trained and receives creatine supplementation', 'interventionNames': ['Dietary Supplement: creatine supplementation']}, {'type': 'EXPERIMENTAL', 'label': 'Creatine and Exercise', 'description': 'this is exercised trained and receives creatine supplementation', 'interventionNames': ['Dietary Supplement: creatine supplementation', 'Other: Resistance training']}], 'interventions': [{'name': 'creatine supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': '20g/d for 7 days followed by 5g/d for 23 weeks', 'armGroupLabels': ['Creatine and Exercise', 'creatine supplementation']}, {'name': 'Placebo (Dextrose)', 'type': 'OTHER', 'description': '20g/d for 7 days followed by 5g/d for 23 weeks', 'armGroupLabels': ['placebo and exercise', 'placebo control']}, {'name': 'Resistance training', 'type': 'OTHER', 'description': 'resistance training twice a week for 24 weeks', 'armGroupLabels': ['Creatine and Exercise', 'placebo and exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508-030', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'School of Medicine - Division of Rheumatology', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Bruno Gualano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Antonio H Lancha Junior, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bruno Gualano', 'investigatorAffiliation': 'University of Sao Paulo'}}}}