- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01164020
Creatine Supplementation and Cognition
January 17, 2013 updated by: Bruno Gualano, University of Sao Paulo
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
São Paulo, Brazil, 05508-030
- School of Medicine - Division of Rheumatology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- women older than 60 years old
Exclusion Criteria:
- cardiovascular diseases or muscular disturbances precluding exercise training
- drugs affecting the cognition
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: placebo control
this only receives placebo (dextrose)
|
20g/d for 7 days followed by 5g/d for 23 weeks
|
|
Experimental: placebo and exercise
this is trained and receives placebo
|
20g/d for 7 days followed by 5g/d for 23 weeks
resistance training twice a week for 24 weeks
|
|
Experimental: creatine supplementation
this is non-exercise trained and receives 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
|
resistance training twice a week for 24 weeks
20g/d for 7 days followed by 5g/d for 23 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
cognitive function
Time Frame: six months
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
physical capacity
Time Frame: six months
|
muscle strength and function
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bruno Gualano, PhD, University of Sao Paulo
- Principal Investigator: Antonio H Lancha Junior, PhD, University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
July 15, 2010
First Submitted That Met QC Criteria
July 15, 2010
First Posted (Estimate)
July 16, 2010
Study Record Updates
Last Update Posted (Estimate)
January 18, 2013
Last Update Submitted That Met QC Criteria
January 17, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- Creatine and Cognition
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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