Beta Alanine SupplementationB-AC3NCT06167395
Study to Analyze the Aerobic Performance Efficacy of Chronic Intake With a β-alanine Supplement in Recreational Cyclists
A study testing Beta Alanine high dose and Beta Alanine low dose in people with Beta Alanine Supplementation, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Randomized, controlled, double-blind, double-blind clinical trial, with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) and single-center, to measure the efficacy of a sustained release beta alanine on the aerobic performance efficacy in recreational… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Beta Alanine Supplementation
- What is being tested?
- Beta Alanine high dose and Beta Alanine low dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteSpain
- Study dates
- 4 Dec 2023to 29 Mar 2024
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male cyclists with more than two years of cycling experience.
- Perform tests without fatigue.
- Road bike training at least twice a week.
Who cannot join
- Participants with chronic illness.
- Have a long-term injury that prevents you from training in the previous month.
- Inability to understand informed consent.
- Have consumed beta alanine in the three years prior to the start of the study.
- Consumption of other supplements that may alter performance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial to Analyze the Efficacy of Chronic Intake of Different Doses of a β-alanine Supplement on Aerobic Performance in Recreational Long-Distance Road Cyclists
Randomized, controlled, double-blind, double-blind clinical trial, with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) and single-center, to measure the efficacy of a sustained release beta alanine on the aerobic performance efficacy in recreational cyclist
Read the detailed description
Subjects meeting the selection criteria will be randomly assigned to each of the study groups (investigational product dose 1 or dose 2, or placebo, depending on the group to which they have been assigned).
The product to be consumed is beta alanine. Participants will consume the product for 30 days. They will have to take 4 intakes every three hours, being the first intake two hours after waking up.
The study subjects will have to make 2 visits to the laboratory. At the first and last visit, their aerobic performance will be evaluated by an incremental test to exhaustion with gas analysis.
- Conditions
- Beta Alanine Supplementation
- Being tested
- Beta Alanine high dose, Beta Alanine low dose, Control product
- Keywords
- Aerobic Performance, Beta Alanine, Supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta Alanine high doseDietary supplement
Subjects should consume 4 intakes of 5 g of beta alanine every 3 hours each day.
Beta Alanine low doseDietary supplement
Subjects should consume 4 intakes of 2,5 g of beta alanine every 3 hours each day.
Control productDietary supplement
Subjects should consume 4 intakes of 2,5 g of wheat semolina every 3 hours each day.
| Study group | Role | What they receive |
|---|---|---|
| Beta Alanine high dose | Experimental | Consumption for 30 days. Receives: Dietary Supplement: Beta Alanine high dose |
| Beta Alanine low dose | Experimental | Consumption for 30 days. Receives: Dietary Supplement: Beta Alanine low dose |
| Control group | Placebo comparator | Consumption for 30 days. Receives: Dietary Supplement: Control product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Power
Measured using a cyclus 2 roller.
Measured: Change in performance after 30 days of product consumption
Distance
Measured using a cyclus 2 roller.
Measured: Change in performance after 30 days of product consumption
Secondary outcomes (7)
Anaerobic treshold
Through a stress test with gas analysis
Measured: It will be measured twice, once at baseline or at the end of the study after 30 days.
Maximum oxygen consumption
Through a stress test with gas analysis
Measured: It will be measured twice, once at baseline or at the end of the study after 30 days.
Aerobic threshold
Through a stress test with gas analysis
Measured: It will be measured twice, once at baseline or at the end of the study after 30 days.
Microcapillary blood
This test provides biochemical variables (ABL90FLEX) with 70 ml of capillary blood.
Measured: It will be measured twice, once at baseline or at the end of the study after 30 days.
Lactate
Lactate levels will be measured using the Lactate Pro 2
Measured: It will be measured twice, once at baseline or at the end of the study after 30 days.
Heart Rate
The heart rate will be evaluated by means of a heart rate strap.
Measured: It will be measured twice, once at baseline or at the end of the study after 30 days.
Fatigue
Rate of perceived exertion
Measured: It will be measured twice, once at baseline or at the end of the study after 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start4 Dec 2023
- Primary completion19 Feb 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta Alanine SupplementationStudies of the same condition, open and under way.
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167395
- Sponsor's protocol ID
- UCAMCFE-00031
- Acronym
- B-AC3
- Status last verified
- Nov 2023
- First submitted
- 2 Dec 2023
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Analyze the Efficacy of Chronic Intake of Different Doses of a β-alanine Supplement on Aerobic Performance in Recreational Long-Distance Road Cyclists
- ClinicalTrials.gov ID
- NCT06167395
- Acronym / sponsor ID
- B-AC3 / UCAMCFE-00031
- Conditions
- Beta Alanine Supplementation
- Keywords
- Aerobic Performance, Beta Alanine, Supplementation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 12 Dec 2023 (actual)
- 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.
Randomized, controlled, double-blind, double-blind clinical trial, with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) and single-center, to measure the efficacy of a sustained release beta alanine on the aerobic performance efficacy in recreational cyclist
Detailed description
Subjects meeting the selection criteria will be randomly assigned to each of the study groups (investigational product dose 1 or dose 2, or placebo, depending on the group to which they have been assigned).
The product to be consumed is beta alanine. Participants will consume the product for 30 days. They will have to take 4 intakes every three hours, being the first intake two hours after waking up.
The study subjects will have to make 2 visits to the laboratory. At the first and last visit, their aerobic performance will be evaluated by an incremental test to exhaustion with gas analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Beta Alanine high dose | Experimental | Dietary Supplement: Beta Alanine high doseConsumption for 30 days. |
| Beta Alanine low dose | Experimental | Dietary Supplement: Beta Alanine low doseConsumption for 30 days. |
| Control group | Placebo comparator | Dietary Supplement: Control productConsumption for 30 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male cyclists with more than two years of cycling experience.
- Perform tests without fatigue.
- Road bike training at least twice a week.
Key exclusion criteria (5 listed)
- Participants with chronic illness.
- Have a long-term injury that prevents you from training in the previous month.
- Inability to understand informed consent.
- Have consumed beta alanine in the three years prior to the start of the study.
- Consumption of other supplements that may alter performance.
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 high doseSubjects should consume 4 intakes of 5 g of beta alanine every 3 hours each day. | Dietary supplement | Beta Alanine high dose |
| Beta Alanine low doseSubjects should consume 4 intakes of 2,5 g of beta alanine every 3 hours each day. | Dietary supplement | Beta Alanine low dose |
| Control productSubjects should consume 4 intakes of 2,5 g of wheat semolina every 3 hours each day. | Dietary supplement | Control group |
Primary outcome
Power
Time frame: Change in performance after 30 days of product consumption
Measured using a cyclus 2 roller.
Distance
Time frame: Change in performance after 30 days of product consumption
Measured using a cyclus 2 roller.
7 secondary outcomes
Anaerobic treshold
Time frame: It will be measured twice, once at baseline or at the end of the study after 30 days.
Maximum oxygen consumption
Time frame: It will be measured twice, once at baseline or at the end of the study after 30 days.
Aerobic threshold
Time frame: It will be measured twice, once at baseline or at the end of the study after 30 days.
Microcapillary blood
Time frame: It will be measured twice, once at baseline or at the end of the study after 30 days.
Lactate
Time frame: It will be measured twice, once at baseline or at the end of the study after 30 days.
Heart Rate
Time frame: It will be measured twice, once at baseline or at the end of the study after 30 days.
Fatigue
Time frame: It will be measured twice, once at baseline or at the end of the study after 30 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 17 May 2024.
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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 high dose and Beta Alanine low dose in people with Beta Alanine Supplementation, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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 3 inclusion and 5 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 17 May 2024. 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 Spain. 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?
Power (time frame: Change in performance after 30 days of product consumption). 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 17 May 2024.