ExerciseNCT01745016
Effect of Beta-Alanine on Heart Rate Response
A study testing Beta-alanine in people with Exercise and Fatigue, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Beta-alanine, as a method to increase muscle carnosine, has been shown to enhance muscle buffering capacity and delay fatigue. Various fatigue tests have been utilized to examine the effectiveness of beta-alanine supplementation. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- What is being tested?
- Beta-alanine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Apr 2013
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18-35 years old
- Be recreationally active (defined as accumulating 1-5 hours of moderate intensity
Who cannot join
- Any health risks or indicators that would prevent them from participating in physical activity, as determined by a health history questionnaire
- Must not have taken performance enhancing supplements containing beta-alanine or creatine during the last 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Exercise and Sport Science
Chapel Hill, North Carolina, 27599
About this study
Official title: The Effect of 28 Days of Beta-alanine Supplementation on the Physical Working Capacity at Heart Rate Threshold (PWCHRT)
Beta-alanine, as a method to increase muscle carnosine, has been shown to enhance muscle buffering capacity and delay fatigue. Various fatigue tests have been utilized to examine the effectiveness of beta-alanine supplementation. The physical working capacity test has been used to show significant increases in physical working capacities following supplementation. The physical working capacity tests were originally developed by Moritani et al. 1981 and Devries et al. 1982 to measure the point of onset of muscular fatigue. It is hypothesized that beta-alanine will increase physical working capacity at heart rate threshold, thereby signifying a delay in fatigue.
Read the detailed description
An equal number of men and women will be recruited [Men, n=20 (10 placebo [PL]; 10 beta-alanine (Active)]; [Women,n=20 (10 PL; 10 Active)]. Men and women will be randomly assigned to respective groups to allow for equal numbers in supplement and placebo groups.
- Being tested
- Placebo, Beta-alanine
- Keywords
- dietary supplement, carnosine
- Medical subject headings
- Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Beta-alanineDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo Receives: Dietary Supplement: Placebo |
| Beta-Alanine | Experimental | beta-alanine Receives: Dietary Supplement: Beta-alanine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical working capacity at heart rate threshold
Measured: 0 to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abbie Smith-Ryan, PhD, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745016
- Sponsor's protocol ID
- 12-1787
- Status last verified
- Apr 2013
- First submitted
- 5 Dec 2012
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 28 Days of Beta-alanine Supplementation on the Physical Working Capacity at Heart Rate Threshold (PWCHRT)
- ClinicalTrials.gov ID
- NCT01745016
- Acronym / sponsor ID
- 12-1787
- Keywords
- dietary supplement, carnosine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 7 Dec 2012 (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.
Beta-alanine, as a method to increase muscle carnosine, has been shown to enhance muscle buffering capacity and delay fatigue. Various fatigue tests have been utilized to examine the effectiveness of beta-alanine supplementation. The physical working capacity test has been used to show significant increases in physical working capacities following supplementation. The physical working capacity tests were originally developed by Moritani et al. 1981 and Devries et al. 1982 to measure the point of onset of muscular fatigue. It is hypothesized that beta-alanine will increase physical working capacity at heart rate threshold, thereby signifying a delay in fatigue.
Detailed description
An equal number of men and women will be recruited [Men, n=20 (10 placebo [PL]; 10 beta-alanine (Active)]; [Women,n=20 (10 PL; 10 Active)]. Men and women will be randomly assigned to respective groups to allow for equal numbers in supplement and placebo groups.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placeboplacebo |
| Beta-Alanine | Experimental | Dietary Supplement: Beta-alaninebeta-alanine |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Between the ages of 18-35 years old
- Be recreationally active (defined as accumulating 1-5 hours of moderate intensity
Key exclusion criteria (2 listed)
- Any health risks or indicators that would prevent them from participating in physical activity, as determined by a health history questionnaire
- Must not have taken performance enhancing supplements containing beta-alanine or creatine during the last 3 months
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 |
|---|---|---|
| Placebo | Dietary supplement | Placebo |
| Beta-alanine | Dietary supplement | Beta-Alanine |
Primary outcome
Physical working capacity at heart rate threshold
Time frame: 0 to 4 weeks
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 30 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Exercise and Fatigue, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 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 30 Apr 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 United States. 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?
Physical working capacity at heart rate threshold (time frame: 0 to 4 weeks). 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 30 Apr 2013.