- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01213719
Effects of Betaine Supplementation on Strength and Muscle Creatine Content
January 12, 2012 updated by: Bruno Gualano, University of Sao Paulo
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sao Paulo, Brazil, 05508-030
- University of Sao Paulo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 28 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- physically inactive
- non-obese
Exclusion Criteria:
- skeletal muscle disturbance
- cardiovascular disturbance
- use of dietary supplements
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: creatine
will receive creatine monohydrate (20g/d) throughout 10 days
|
20g/d throughout 10 days
|
Experimental: betaine
will receive betaine (2g/d) throughout 10 days
|
2g/d throughout 10 days
|
Placebo Comparator: placebo (dextrose)
will receive dextrose(20g/d)throughout 10 days.
|
dextrose (placebo), 20 g/d throughout 10 days
|
Active Comparator: creatine plus betaine
will receive creatine (20g/d) plus betaine (2g/d) throughout 10 days
|
creatine (20g/d) plus betaine (2g/d) throughout 10 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
strength
Time Frame: after 10 days
|
after 10 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
intramuscular creatine content
Time Frame: after 10 days
|
after 10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Bruno Gualano, PhD, University of Sao Paulo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
October 1, 2010
First Submitted That Met QC Criteria
October 1, 2010
First Posted (Estimate)
October 4, 2010
Study Record Updates
Last Update Posted (Estimate)
January 16, 2012
Last Update Submitted That Met QC Criteria
January 12, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- betaine supplementation
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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