Healthy SubjectsNCT01213719
Effects of Betaine Supplementation on Strength and Muscle Creatine Content
A study testing creatine, betaine and dextrose in people with Healthy Subjects, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
It has been suggested that betaine supplementation may improve muscle strength by increasing muscle creatine content. However, there is no data supporting this assumption. The investigators speculate that betaine supplementation could enhance intramuscular creatine content, which would result in strength improvements. 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 Subjects
- What is being tested?
- creatine, betaine and dextrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2010to Jul 2011
- 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
- physically inactive
- non-obese
Who cannot join
- skeletal muscle disturbance
- cardiovascular disturbance
- use of dietary supplements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Betaine Supplementation Combined or Not With Creatine Supplementation on Muscle Creatine Content and Strength
It has been suggested that betaine supplementation may improve muscle strength by increasing muscle creatine content. However, there is no data supporting this assumption. The investigators speculate that betaine supplementation could enhance intramuscular creatine content, which would result in strength improvements.
- Conditions
- Healthy Subjects
- Being tested
- creatine, betaine, dextrose, creatine plus betaine
- Keywords
- betaine, creatine, strength
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
creatineDietary supplement
20g/d throughout 10 days
betaineDietary supplement
2g/d throughout 10 days
dextroseDietary supplement
dextrose (placebo), 20 g/d throughout 10 days
creatine plus betaineDietary supplement
creatine (20g/d) plus betaine (2g/d) throughout 10 days
| Study group | Role | What they receive |
|---|---|---|
| creatine | Experimental | will receive creatine monohydrate (20g/d) throughout 10 days Receives: Dietary Supplement: creatine |
| betaine | Experimental | will receive betaine (2g/d) throughout 10 days Receives: Dietary Supplement: betaine |
| placebo (dextrose) | Placebo comparator | will receive dextrose(20g/d)throughout 10 days. Receives: Dietary Supplement: dextrose |
| creatine plus betaine | Active comparator | will receive creatine (20g/d) plus betaine (2g/d) throughout 10 days Receives: Dietary Supplement: creatine plus betaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
strength
Measured: after 10 days
Secondary outcomes (1)
intramuscular creatine content
Measured: after 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- 40 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, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213719
- Sponsor's protocol ID
- betaine supplementation
- Status last verified
- Jan 2012
- First submitted
- 1 Oct 2010
- Last updated
- 16 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Betaine Supplementation Combined or Not With Creatine Supplementation on Muscle Creatine Content and Strength
- ClinicalTrials.gov ID
- NCT01213719
- Acronym / sponsor ID
- betaine supplementation
- Conditions
- Healthy Subjects
- Keywords
- betaine, creatine, strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 Oct 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.
It has been suggested that betaine supplementation may improve muscle strength by increasing muscle creatine content. However, there is no data supporting this assumption. The investigators speculate that betaine supplementation could enhance intramuscular creatine content, which would result in strength improvements.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| creatine | Experimental | Dietary Supplement: creatinewill receive creatine monohydrate (20g/d) throughout 10 days |
| betaine | Experimental | Dietary Supplement: betainewill receive betaine (2g/d) throughout 10 days |
| placebo (dextrose) | Placebo comparator | Dietary Supplement: dextrosewill receive dextrose(20g/d)throughout 10 days. |
| creatine plus betaine | Active comparator | Dietary Supplement: creatine plus betainewill receive creatine (20g/d) plus betaine (2g/d) throughout 10 days |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- physically inactive
- non-obese
Key exclusion criteria (3 listed)
- skeletal muscle disturbance
- cardiovascular disturbance
- use of dietary supplements
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 |
|---|---|---|
| creatine20g/d throughout 10 days | Dietary supplement | creatine |
| betaine2g/d throughout 10 days | Dietary supplement | betaine |
| dextrosedextrose (placebo), 20 g/d throughout 10 days | Dietary supplement | placebo (dextrose) |
| creatine plus betainecreatine (20g/d) plus betaine (2g/d) throughout 10 days | Dietary supplement | creatine plus betaine |
Primary outcome
strength
Time frame: after 10 days
1 secondary outcome
intramuscular creatine content
Time frame: after 10 days
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 16 Jan 2012.
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
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 study director
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, betaine and dextrose in people with Healthy Subjects, 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 3 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 16 Jan 2012. 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?
strength (time frame: after 10 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 16 Jan 2012.