Effects of Creatine Supplementation on Renal Function

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Completed
• CT.gov ID: NCT00465140
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Duration (Months): 36
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Insufficiency	Drug: creatine supplementation; Behavioral: aerobic exercise training	N/A

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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
• Study Start Date: Jan 1, 2004
• Actual Study Completion Date: Jan 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00465140
• Other Study ID Numbers: EEFEUSP-021284
• First Posted: Apr 24, 2007
• Last Update Posted: Apr 24, 2007
• Last Verified: Apr 1, 2007

• Additional relevant MeSH terms: Renal Insufficiency

Study Results

No Results Posted as of Apr 24, 2007