Effects of Creatine Supplementation on Renal Function
Primary Purpose
Renal Insufficiency
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
creatine supplementation
aerobic exercise training
Sponsored by
About this trial
This is an interventional prevention trial for Renal Insufficiency
Eligibility Criteria
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
Sites / Locations
- University of Sao Paulo
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00465140
Brief Title
Effects of Creatine Supplementation on Renal Function
Official Title
Effects of Creatine Supplementation on Renal Function in Sedentary Healthy Males Urdergoing Aerobic Training: a Randomized, Double-Blind, Placebo-Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
18 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
creatine supplementation
Intervention Type
Behavioral
Intervention Name(s)
aerobic exercise training
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Gualano, ms
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
55 11
Country
Brazil
12. IPD Sharing Statement
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Effects of Creatine Supplementation on Renal Function
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