HealthyNCT01803230
Creatine Supplementation on Cognition in Children
A study testing creatine supplementation in people with Healthy, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Creatine supplementation may improve cognitive function in elderly and vegetarian individuals. This study aims to investigate the role of creatine supplementation on cognitive function in healthy children. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- creatine supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2013to Feb 2015
- 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 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy children
- age between 10 to 12 years of age
Who cannot join
- cognitive impairment
- vegetarian diet
- use of creatine in the past 6 months
- chronic kidney disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo
São Paulo, São Paulo
Carlos Merege, 5511 30913096, carlosmeregefilho@gmail.com
Bruno Gualano, Professor
About this study
Official title: Effects of Creatine Supplementation on Cognitive Function in Children
Creatine supplementation may improve cognitive function in elderly and vegetarian individuals. This study aims to investigate the role of creatine supplementation on cognitive function in healthy children.
- Conditions
- Healthy
- Being tested
- creatine supplementation, Placebo
- Keywords
- children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
creatine supplementationDietary supplement
creatine supplementation
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo (dextrose) Receives: Dietary Supplement: Placebo |
| creatine | Experimental | creatine supplementation Receives: Dietary Supplement: creatine supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive function
assessed by a battery of cognitive tests as follows: colors and words attention test, controlled words association test, memory and figures learning, mental flexibility test and inhibitory control, digit span test, and intelligence quotient.
Measured: 7 days
Secondary outcomes (1)
tissue creatine content
as assessed by 1H-MRS.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
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
- NCT01803230
- Sponsor's protocol ID
- Creatine in Children
- Status last verified
- Feb 2013
- First submitted
- 27 Feb 2013
- Last updated
- 4 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Creatine Supplementation on Cognitive Function in Children
- ClinicalTrials.gov ID
- NCT01803230
- Acronym / sponsor ID
- Creatine in Children
- Conditions
- Healthy
- Keywords
- children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 4 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.
Creatine supplementation may improve cognitive function in elderly and vegetarian individuals. This study aims to investigate the role of creatine supplementation on cognitive function in healthy children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Dietary Supplement: Placeboplacebo (dextrose) |
| creatine | Experimental | Dietary Supplement: creatine supplementationcreatine supplementation |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- healthy children
- age between 10 to 12 years of age
Key exclusion criteria (4 listed)
- cognitive impairment
- vegetarian diet
- use of creatine in the past 6 months
- chronic kidney disease
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 |
|---|---|---|
| creatine supplementationcreatine supplementation | Dietary supplement | creatine |
| Placebo | Dietary supplement | placebo |
Primary outcome
cognitive function
Time frame: 7 days
assessed by a battery of cognitive tests as follows: colors and words attention test, controlled words association test, memory and figures learning, mental flexibility test and inhibitory control, digit span test, and intelligence quotient.
1 secondary outcome
tissue creatine content
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2013.
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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 supplementation in people with Healthy, 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: status not confirmed, as of the sponsor's last update on 4 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Merege (551130913096, carlosmeregefilho@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive function (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2013.