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CompletedNCT00465140Updated Apr 24, 2007

Effects of Creatine Supplementation on Renal Function

An interventional study of creatine supplementation and aerobic exercise training in Renal Insufficiency, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-04-24.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Renal Insufficiency

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03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 18 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Sedentary healthy males,
  • Euthrofic,
  • Age beteween 18-35 y

Exclusion criteria

Exclusion Criteria:

  • Food supplement users,
  • Pre-existing renal dysfunction,
  • Pre-existing cardioavascular disease,
  • Subjetcs physically active or athletes,
  • Obesity,
  • Drugs users
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
18 participants

Interventions

  • Drugcreatine supplementation
  • Behavioralaerobic exercise training
06

Study locations

1 site
  • University of Sao Paulo
    Sao Paulo, 55 11, Brazil
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00465140
Lead sponsor
University of Sao Paulo
First posted
Apr 24, 2007
Start date
Jan 2004
Completion
Jan 2007
Last update
Apr 24, 2007

Study contacts

Bruno Gualano, ms
principal investigator · University of Sao Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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