NCT01817673

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 25, 2013

Completed
Last Updated

March 25, 2013

Status Verified

March 1, 2013

Enrollment Period

1.6 years

First QC Date

March 20, 2013

Last Update Submit

March 22, 2013

Conditions

Healthy Persons

Outcome Measures

Primary Outcomes (1)

  • kidney function

    as assessed by 51Cr-EDTA clearance

    3 months

Secondary Outcomes (4)

  • proteinuria

    3 months

  • albuminuria

    3 months

  • serum urea

    3 months

  • serum creatinine

    3 months

Study Arms (2)

creatine

EXPERIMENTAL

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

Dietary Supplement: creatine

placebo (dextrose)

PLACEBO COMPARATOR

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

Dietary Supplement: placebo

Interventions

creatineDIETARY_SUPPLEMENT

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

creatine
placeboDIETARY_SUPPLEMENT
placebo (dextrose)

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univsersity of Sao Paulo

São Paulo, São Paulo, 05508-030, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 23680457DERIVED

MeSH Terms

Interventions

Creatine

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Bruno Gualano, Professor

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 20, 2013

First Posted

March 25, 2013

Study Start

July 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

March 25, 2013

Record last verified: 2013-03

Locations

BR(1)