Spinal Cord InjuriesNCT02604927
Beta-alanine Supplementation and Its Effects on Performance, Muscle Carnosine Content and Safety in Athletes With Spinal-cord Injury
A study testing Beta-alanine and Dextrose in people with Spinal Cord Injuries, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Beta-alanine and Dextrose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2016to Sep 2017
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Physical Education and Sports, University of Sao Paulo
São Paulo, São Paulo, 05508-030
Guilherme Artioli, PhD, 55 11 3091-3096, artioli@usp.br
About this study
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Beta-alanine, Dextrose
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-alanineDietary supplement
DextroseDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 800 mg of dextrose, four times per day, during 28 days. Receives: Dietary Supplement: Dextrose |
| Beta-alanine | Experimental | 800 mg of beta-alanine, four times per day, during 28 days. Receives: Dietary Supplement: Beta-alanine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise performance (Time to exhaustion test)
Time to exhaustion test performed on arm crank ergometer
Measured: 28 days
Muscle carnosine content before and after supplementation
Assessed by muscle biopsy samples before performance tests
Measured: 28 days
Secondary outcomes (3)
Muscle carnosine content in trained (deltoid) vs. untrained (vastus lateralis) muscles
Deltoids microbiopsy and vastus lateralis biopsy
Measured: 28 days
Blood pH.
1 mL venous blood sample
Measured: 5 minutes after performance tests
Safety of beta-alanine supplementation measured by complete hemogram analysis
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startFeb 2016
- Primary completionNov 2016 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604927
- Sponsor's protocol ID
- B-Alanine Paraplegic Athletes
- Status last verified
- Nov 2015
- First submitted
- 22 Sep 2015
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-alanine Supplementation and Its Effects on Performance, Muscle Carnosine Content and Safety in Athletes With Spinal-cord Injury
- ClinicalTrials.gov ID
- NCT02604927
- Acronym / sponsor ID
- B-Alanine Paraplegic Athletes
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 16 Nov 2015 (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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Dextrose800 mg of dextrose, four times per day, during 28 days. |
| Beta-alanine | Experimental | Dietary Supplement: Beta-alanine800 mg of beta-alanine, four times per day, during 28 days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Beta-alanine | Dietary supplement | Beta-alanine |
| Dextrose | Dietary supplement | Placebo |
Primary outcome
Exercise performance (Time to exhaustion test)
Time frame: 28 days
Time to exhaustion test performed on arm crank ergometer
Muscle carnosine content before and after supplementation
Time frame: 28 days
Assessed by muscle biopsy samples before performance tests
3 secondary outcomes
Muscle carnosine content in trained (deltoid) vs. untrained (vastus lateralis) muscles
Time frame: 28 days
Blood pH.
Time frame: 5 minutes after performance tests
Safety of beta-alanine supplementation measured by complete hemogram analysis
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-alanine and Dextrose in people with Spinal Cord Injuries, 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 4 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 16 Nov 2015. 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 Guilherme Artioli, PhD (55 11 30913096, artioli@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise performance (Time to exhaustion test) (time frame: 28 days). The study lists 2 primary outcomes in all. 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 Nov 2015.