Healthy PersonsNCT01817673
Creatine Supplementation on Kidney Function in Resistance-trained Individuals
A study testing creatine in people with Healthy Persons, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Persons
- What is being tested?
- creatine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2011to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- participation in recreational resistance training
- consumption of a high-protein diet (≥ 1.2 g/Kg/d)
Who cannot join
- vegetarian diet
- use of creatine supplements in the past 6 months
- chronic kidney disease
- use of anabolic steroids.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy Persons
- Being tested
- creatine, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
creatineDietary supplement
20 g/d for 5 d followed by 5 g/d throughout the trial
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| creatine | Experimental | 20 g/d for 5 d followed by 5 g/d throughout the trial Receives: Dietary Supplement: creatine |
| placebo (dextrose) | Placebo comparator | 20 g/d for 5 d followed by 5 g/d throughout the trial Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
kidney function
as assessed by 51Cr-EDTA clearance
Measured: 3 months
Secondary outcomes (4)
proteinuria
Measured: 3 months
albuminuria
Measured: 3 months
serum urea
Measured: 3 months
serum creatinine
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study startJul 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy PersonsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
- Investigators
- Bruno Gualano, Professor, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817673
- Sponsor's protocol ID
- Creatine & kidney
- Status last verified
- Mar 2013
- First submitted
- 20 Mar 2013
- Last updated
- 25 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creatine Supplementation on Kidney Function in Resistance-trained Individuals
- ClinicalTrials.gov ID
- NCT01817673
- Acronym / sponsor ID
- Creatine & kidney
- Conditions
- Healthy Persons
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 25 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| creatine | Experimental | Dietary Supplement: creatine20 g/d for 5 d followed by 5 g/d throughout the trial |
| placebo (dextrose) | Placebo comparator | Dietary Supplement: placebo20 g/d for 5 d followed by 5 g/d throughout the trial |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- participation in recreational resistance training
- consumption of a high-protein diet (≥ 1.2 g/Kg/d)
Key exclusion criteria (4 listed)
- vegetarian diet
- use of creatine supplements in the past 6 months
- chronic kidney disease
- use of anabolic steroids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| creatine20 g/d for 5 d followed by 5 g/d throughout the trial | Dietary supplement | creatine |
| placebo | Dietary supplement | placebo (dextrose) |
Primary outcome
kidney function
Time frame: 3 months
as assessed by 51Cr-EDTA clearance
4 secondary outcomes
proteinuria
Time frame: 3 months
albuminuria
Time frame: 3 months
serum urea
Time frame: 3 months
serum creatinine
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2013.
- Derived from this study: PubMed 23680457Lugaresi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Gualano, Professor principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing creatine in people with Healthy Persons, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
kidney function (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01817673, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2013.