Effects of Creatine Supplementation on Renal Function

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00465140
First received: April 23, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Renal Insufficiency
Drug: creatine supplementation
Behavioral: aerobic exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Effects of Creatine Supplementation on Renal Function in Sedentary Healthy Males Urdergoing Aerobic Training: a Randomized, Double-Blind, Placebo-Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Estimated Enrollment: 18
Study Start Date: January 2004
Study Completion Date: January 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00465140

Locations
Brazil
University of Sao Paulo
Sao Paulo, Brazil, 55 11
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Bruno Gualano, ms University of Sao Paulo
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00465140     History of Changes
Other Study ID Numbers: EEFEUSP-021284
Study First Received: April 23, 2007
Last Updated: April 23, 2007
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 28, 2014