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Creatine Supplementation and Cognition

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01164020
First received: July 15, 2010
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Cognition
Aging
 Dietary Supplement: creatine supplementation
Other: Placebo (Dextrose)
Other: Resistance training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • cognitive function [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • physical capacity [ Time Frame: six months ] [ Designated as safety issue: No ]
    muscle strength and function


Enrollment: 56
Study Start Date: August 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo control
this only receives placebo (dextrose)
 Other: Placebo (Dextrose)
20g/d for 7 days followed by 5g/d for 23 weeks
Experimental: placebo and exercise
this is trained and receives placebo
 Other: Placebo (Dextrose)
20g/d for 7 days followed by 5g/d for 23 weeks
Other: Resistance training
resistance training twice a week for 24 weeks
Experimental: creatine supplementation
this is non-exercise trained and receives creatine supplementation
 Dietary Supplement: creatine supplementation
20g/d for 7 days followed by 5g/d for 23 weeks
Experimental: Creatine and Exercise
this is exercised trained and receives creatine supplementation
 Dietary Supplement: creatine supplementation
20g/d for 7 days followed by 5g/d for 23 weeks
Other: Resistance training
resistance training twice a week for 24 weeks

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women older than 60 years old

Exclusion Criteria:

  • cardiovascular diseases or muscular disturbances precluding exercise training
  • drugs affecting the cognition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01164020

Locations
Brazil
School of Medicine - Division of Rheumatology
São Paulo, Brazil, 05508-030
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Bruno Gualano, PhD University of Sao Paulo
Principal Investigator: Antonio H Lancha Junior, PhD University of Sao Paulo
  More Information

No publications provided

Responsible Party: Bruno Gualano, Principal Investigator, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01164020     History of Changes
Other Study ID Numbers: Creatine and Cognition
Study First Received: July 15, 2010
Last Updated: January 17, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
cognition
supplementation creatine
resistance training
aging

ClinicalTrials.gov processed this record on May 23, 2013