- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01817673
Creatine Supplementation on Kidney Function in Resistance-trained Individuals
March 22, 2013 updated by: Bruno Gualano, University of Sao Paulo
There is a claim that creatine supplementation might affect kidney function, especially in those consuming a high-protein diet.
The aim of this study was to investigate the effects of creatine supplementation on kidney function in resistance-trained individuals ingesting a high-protein diet.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
46
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
-
-
-
Sao Paulo, Brazil, 05508-030
- Univsersity of Sao Paulo
-
-
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
18 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- participation in recreational resistance training
- consumption of a high-protein diet (≥ 1.2 g/Kg/d)
Exclusion Criteria:
- vegetarian diet
- use of creatine supplements in the past 6 months
- chronic kidney disease
- use of anabolic steroids.
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
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: creatine
20 g/d for 5 d followed by 5 g/d throughout the trial
|
20 g/d for 5 d followed by 5 g/d throughout the trial
|
Placebo Comparator: placebo (dextrose)
20 g/d for 5 d followed by 5 g/d throughout the trial
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
kidney function
Time Frame: 3 months
|
as assessed by 51Cr-EDTA clearance
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
proteinuria
Time Frame: 3 months
|
3 months
|
albuminuria
Time Frame: 3 months
|
3 months
|
serum urea
Time Frame: 3 months
|
3 months
|
serum creatinine
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
July 1, 2011
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
March 20, 2013
First Submitted That Met QC Criteria
March 22, 2013
First Posted (Estimate)
March 25, 2013
Study Record Updates
Last Update Posted (Estimate)
March 25, 2013
Last Update Submitted That Met QC Criteria
March 22, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- Creatine & kidney
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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