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CompletedNCT01817673Updated Mar 25, 2013

Creatine Supplementation on Kidney Function in Resistance-trained Individuals

An interventional study of creatine and placebo in Healthy Persons, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-03-25.

Sponsored by University of Sao Paulo · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Male
01

Study summary

There is a claim that creatine supplementation might affect kidney function, especially in those consuming a high-protein diet. The aim of this study was to investigate the effects of creatine supplementation on kidney function in resistance-trained individuals ingesting a high-protein diet.

02

Conditions studied

  • Healthy Persons
03

In context

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 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • participation in recreational resistance training
  • consumption of a high-protein diet (≥ 1.2 g/Kg/d)

Exclusion criteria

Exclusion Criteria:

  • vegetarian diet
  • use of creatine supplements in the past 6 months
  • chronic kidney disease
  • use of anabolic steroids.
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    creatine

    20 g/d for 5 d followed by 5 g/d throughout the trial

    Dietary Supplement: creatine

  • Placebo comparator
    placebo (dextrose)

    20 g/d for 5 d followed by 5 g/d throughout the trial

    Dietary Supplement: placebo

Interventions

  • Dietary supplementcreatine

    20 g/d for 5 d followed by 5 g/d throughout the trial

  • Dietary supplementplacebo
06

What researchers measure

Primary outcomes

  1. kidney function

    as assessed by 51Cr-EDTA clearance

    Time frame: 3 months

Secondary outcomes

  1. proteinuria

    Time frame: 3 months

  2. albuminuria

    Time frame: 3 months

  3. serum urea

    Time frame: 3 months

  4. serum creatinine

    Time frame: 3 months

07

Study locations

1 site
  • Univsersity of Sao Paulo
    Sao Paulo, 05508-030, Brazil
08

References and documents

Publications

  • Lugaresi R, Leme M, de Salles Painelli V, Murai IH, Roschel H, Sapienza MT, Lancha Junior AH, Gualano B. Does long-term creatine supplementation impair kidney function in resistance-trained individuals consuming a high-protein diet? J Int Soc Sports Nutr. 2013 May 16;10(1):26. doi: 10.1186/1550-2783-10-26. PubMed 23680457 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01817673
Lead sponsor
University of Sao Paulo
Responsible party
Bruno Gualano (Professor, University of Sao Paulo) — Principal investigator
First posted
Mar 25, 2013
Start date
Jul 2011
Primary completion
Feb 2013
Completion
Feb 2013
Last update
Mar 25, 2013

Study contacts

Bruno Gualano, Professor
principal investigator · University of Sao Paulo

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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