- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00465140
Effects of Creatine Supplementation on Renal Function
April 23, 2007 updated by: University of Sao Paulo
Effects of Creatine Supplementation on Renal Function in Sedentary Healthy Males Urdergoing Aerobic Training: a Randomized, Double-Blind, Placebo-Controlled Trial
Creatine (CR) supplementation is commonly used by athletes.
However, its effects on renal function remain controversial.
The aim of this study was to evaluate the effects of creatine supplementation on renal function and oxidative stress in healthy sedentary males (18-35 years old) submitted to exercise training.
Our hipothesis is that creatine supplementation does not affect renal function in this population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Creatine (CR) supplementation is commonly used by athletes.
However, its effects on renal function remain controversial.
Purpose: The aim of this study was to evaluate the effects of creatine supplementation on renal function and oxidative stress in healthy sedentary males (18-35 years old) submitted to exercise training.
Methods: Subjects (n = 18) were randomly divided in two groups and were allocated to receive treatment with either creatine (CR) (~10g • day-1 over three months) or placebo (PL) (dextrose).
All subjects undertook moderate intensity aerobic training, in three 40-minute sessions per week, during 3 months.
Serum creatinine, TBARS, serum and urinary sodium and potassium were determined at baseline and at the study endpoint.
Furthermore, cystatin C was also assessed prior to training (PRE), after 4 (POST 4) and 12 weeks (POST 12).
Results: There were decreased in both oxidative stress (evaluated by TBARS - µM/24 h) (PRE CR: 8.2 4.4; PL: 6.4 0.8 vs. POST 12 CR: 2.5 1.8; PL: 2.1 1.6, p=0.0001) and cystatin C levels (mg/L) (PRE CR:0.82 0.09; PL: 0.88 0.07 vs. POST 12 CR: 0.71 0.06; PL: 0.75 0.09, p=0.0001) over the time, suggesting an increase in glomerular filtration rate.
There were no significant differences between groups in other renal parameters investigated.
Conclusions: These data indicate that high-dose creatine supplementation throughout three months does not provoke renal dysfunction in sedentary healthy males urdergoing aerobic training.
Moreover, our results suggest that moderate aerobic training per se could improve renal function.
Study Type
Interventional
Enrollment
18
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
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Sao Paulo, Brazil, 55 11
- University of Sao Paulo
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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 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Sedentary healthy males,
- Euthrofic,
- Age beteween 18-35 y
Exclusion Criteria:
- Food supplement users,
- Pre-existing renal dysfunction,
- Pre-existing cardioavascular disease,
- Subjetcs physically active or athletes,
- Obesity,
- Drugs users
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bruno Gualano, ms, University of Sao Paulo
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
January 1, 2004
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
April 23, 2007
First Submitted That Met QC Criteria
April 23, 2007
First Posted (Estimate)
April 24, 2007
Study Record Updates
Last Update Posted (Estimate)
April 24, 2007
Last Update Submitted That Met QC Criteria
April 23, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EEFEUSP-021284
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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