CognitionNCT01164020
Creatine Supplementation and Cognition
A study testing creatine supplementation and Resistance training in people with Cognition and Aging, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Resistance training as well as creatine supplementation may be beneficial for cognitive function, such as memory and attention. Therefore, the investigators speculate that resistance training combined with creatine supplementation would promote additive benefits on cognitive function in elderly women. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- What is being tested?
- creatine supplementation and Resistance training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2010to Dec 2012
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women older than 60 years old
Who cannot join
- cardiovascular diseases or muscular disturbances precluding exercise training
- drugs affecting the cognition
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Medicine - Division of Rheumatology
São Paulo, São Paulo, 05508-030
About this study
Resistance training as well as creatine supplementation may be beneficial for cognitive function, such as memory and attention. Therefore, the investigators speculate that resistance training combined with creatine supplementation would promote additive benefits on cognitive function in elderly women.
- Being tested
- creatine supplementation, Placebo (Dextrose), Resistance training
- Keywords
- cognition, supplementation creatine, resistance training, aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
creatine supplementationDietary supplement
20g/d for 7 days followed by 5g/d for 23 weeks
Placebo (Dextrose)Other
20g/d for 7 days followed by 5g/d for 23 weeks
Resistance trainingOther
resistance training twice a week for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| placebo control | Placebo comparator | this only receives placebo (dextrose) Receives: Other: Placebo (Dextrose) |
| placebo and exercise | Experimental | this is trained and receives placebo Receives: Other: Placebo (Dextrose); Other: Resistance training |
| creatine supplementation | Experimental | this is non-exercise trained and receives creatine supplementation Receives: Dietary Supplement: creatine supplementation |
| Creatine and Exercise | Experimental | this is exercised trained and receives creatine supplementation Receives: Dietary Supplement: creatine supplementation; Other: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive function
Measured: six months
Secondary outcomes (1)
physical capacity
muscle strength and function
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2012
- Study completionDec 2012
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 CognitionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 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, PhD, Principal investigator, University of Sao PauloAntonio H Lancha Junior, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164020
- Sponsor's protocol ID
- Creatine and Cognition
- Status last verified
- Jan 2013
- First submitted
- 15 Jul 2010
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Alves CR, Merege Filho CA, Benatti FB, Brucki S, Pereira RM, de Sa Pinto AL, Lima FR, Roschel H, Gualano B. Creatine supplementation associated or not with strength training upon emotional and cognitive measures in older women: a randomized double-blind study. PLoS One. 2013 Oct 3;8(10):e76301. doi: 10.1371/journal.pone.0076301. eCollection 2013.
PubMed 24098469
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creatine Supplementation and Cognition
- ClinicalTrials.gov ID
- NCT01164020
- Acronym / sponsor ID
- Creatine and Cognition
- Keywords
- cognition, supplementation creatine, resistance training, aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Jul 2010 (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.
Resistance training as well as creatine supplementation may be beneficial for cognitive function, such as memory and attention. Therefore, the investigators speculate that resistance training combined with creatine supplementation would promote additive benefits on cognitive function in elderly women.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| placebo control | Placebo comparator | Other: Placebo (Dextrose)this only receives placebo (dextrose) |
| placebo and exercise | Experimental | Other: Placebo (Dextrose), Other: Resistance trainingthis is trained and receives placebo |
| creatine supplementation | Experimental | Dietary Supplement: creatine supplementationthis is non-exercise trained and receives creatine supplementation |
| Creatine and Exercise | Experimental | Dietary Supplement: creatine supplementation, Other: Resistance trainingthis is exercised trained and receives creatine supplementation |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women older than 60 years old
Key exclusion criteria (2 listed)
- cardiovascular diseases or muscular disturbances precluding exercise training
- drugs affecting the cognition
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 supplementation20g/d for 7 days followed by 5g/d for 23 weeks | Dietary supplement | Creatine and Exercise, creatine supplementation |
| Placebo (Dextrose)20g/d for 7 days followed by 5g/d for 23 weeks | Other | placebo and exercise, placebo control |
| Resistance trainingresistance training twice a week for 24 weeks | Other | Creatine and Exercise, placebo and exercise |
Primary outcome
cognitive function
Time frame: six months
1 secondary outcome
physical capacity
Time frame: six 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 18 Jan 2013.
- Derived from this study: PubMed 24098469Alves CR, Merege Filho CA, Benatti FB, Brucki S, Pereira RM, de Sa Pinto AL, Lima FR, Roschel H, Gualano B. Creatine supplementation associated or not with strength training upon emotional and cognitive measures in older women: a randomized double-blind study. PLoS One. 2013 Oct 3;8(10):e76301. doi: 10.1371/journal.pone.0076301. eCollection 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, PhD principal investigator
University of Sao Paulo
Antonio H Lancha Junior, PhD 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 and Resistance training in people with Cognition and Aging, 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 1 inclusion and 2 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 18 Jan 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?
cognitive function (time frame: six 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 NCT01164020, 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 18 Jan 2013.