- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02604927
Beta-alanine Supplementation and Its Effects on Performance, Muscle Carnosine Content and Safety in Athletes With Spinal-cord Injury
November 11, 2015 updated by: Bruno Gualano, University of Sao Paulo
Paralympians competing in wheelchair sports may experience a very high glycolytic demand (and therefore acidotic environment) in their upper-body muscles, particularly in high-intensity disciplines.
Previous studies from our group have shown that upper-body exercise is very sensitive to the ergogenic effects of β-alanine supplementation and to other nutritional supplements capable of increasing buffering capacity.
In line with this, have shown that upper-body muscle groups benefit more from artificially induced alkalosis than lower-body muscle groups.
Although β-alanine appears to be an interesting and potential ergogenic supplement for paralympians, no study to date has assessed its potential in wheelchair athletes.In this study, we will evaluate the effects of β-alanine supplementation on upper-body performance in wheelchair athletes.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
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
-
-
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São Paulo, Brazil, 05508-030
- School of Physical Education and Sports, University of Sao Paulo
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-
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
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Paralympian training for any exercise modality for at least one year;
- A weekly training volume of 6 hours or more;
- Have a spinal cord injury accompanied by loss of motor function in the lower limbs for at least one year;
- Available for carrying out the experimental procedures.
Exclusion Criteria:
- Use of creatine or beta-alanine for at least 3 and 6 months before the trial;
- Cardiovascular or respiratory disease;
- Clinical condition that result in malabsorption of nutrients;
- Any other medical condition that prevents the realization of experimental procedures.
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
800 mg of dextrose, four times per day, during 28 days.
|
|
|
Experimental: Beta-alanine
800 mg of beta-alanine, four times per day, during 28 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise performance (Time to exhaustion test)
Time Frame: 28 days
|
Time to exhaustion test performed on arm crank ergometer
|
28 days
|
|
Muscle carnosine content before and after supplementation
Time Frame: 28 days
|
Assessed by muscle biopsy samples before performance tests
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle carnosine content in trained (deltoid) vs. untrained (vastus lateralis) muscles
Time Frame: 28 days
|
Deltoids microbiopsy and vastus lateralis biopsy
|
28 days
|
|
Blood pH.
Time Frame: 5 minutes after performance tests
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1 mL venous blood sample
|
5 minutes after performance tests
|
|
Safety of beta-alanine supplementation measured by complete hemogram analysis
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
February 1, 2016
Primary Completion (Anticipated)
November 1, 2016
Study Completion (Anticipated)
September 1, 2017
Study Registration Dates
First Submitted
September 22, 2015
First Submitted That Met QC Criteria
November 11, 2015
First Posted (Estimate)
November 16, 2015
Study Record Updates
Last Update Posted (Estimate)
November 16, 2015
Last Update Submitted That Met QC Criteria
November 11, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-Alanine Paraplegic Athletes
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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