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Creatine Supplementation on Kidney Function in Resistance-trained Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01817673
Recruitment Status : Completed
First Posted : March 25, 2013
Last Update Posted : March 25, 2013
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE March 20, 2013
First Posted Date  ICMJE March 25, 2013
Last Update Posted Date March 25, 2013
Study Start Date  ICMJE July 2011
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2013)
kidney function [ Time Frame: 3 months ]
as assessed by 51Cr-EDTA clearance
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2013)
  • proteinuria [ Time Frame: 3 months ]
  • albuminuria [ Time Frame: 3 months ]
  • serum urea [ Time Frame: 3 months ]
  • serum creatinine [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Creatine Supplementation on Kidney Function in Resistance-trained Individuals
Official Title  ICMJE Not Provided
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Healthy Persons
Intervention  ICMJE
  • Dietary Supplement: creatine
    20 g/d for 5 d followed by 5 g/d throughout the trial
  • Dietary Supplement: placebo
Study Arms  ICMJE
  • Experimental: creatine
    20 g/d for 5 d followed by 5 g/d throughout the trial
    Intervention: Dietary Supplement: creatine
  • Placebo Comparator: placebo (dextrose)
    20 g/d for 5 d followed by 5 g/d throughout the trial
    Intervention: Dietary Supplement: placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 22, 2013)
46
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • vegetarian diet
  • use of creatine supplements in the past 6 months
  • chronic kidney disease
  • use of anabolic steroids.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01817673
Other Study ID Numbers  ICMJE Creatine & kidney
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bruno Gualano, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bruno Gualano, Professor University of Sao Paulo
PRS Account University of Sao Paulo
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP