Effects of Creatine Supplementation on Renal Function

Renal Insufficiency Clinical Trial

Official title:

Effects of Creatine Supplementation on Renal Function in Sedentary Healthy Males Urdergoing Aerobic Training: a Randomized, Double-Blind, Placebo-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00465140
• Other study ID #: EEFEUSP-021284
• Status: Completed
• Phase: N/A
• First received: April 23, 2007
• Last updated: April 23, 2007
• Start date: January 2004
• Est. completion date: January 2007

Study information

• Verified date: April 2007
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Drug:
• creatine supplementation

Behavioral:
• aerobic exercise training

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil,