Beta Alanine SupplementationB-AC2NCT06191055
Study to Analyze the 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, single-center, controlled clinical trial with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) to measure the efficacy of 28-day consumption of a sustained-release beta alanine on the physiological efficacy of… 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 11 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 Performance in Recreational Cross-country Road Cyclists
Randomized, controlled, double-blind, single-center, controlled clinical trial with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) to measure the efficacy of 28-day consumption of a sustained-release beta alanine on the physiological efficacy of physical performance in recreational cyclists.
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 28 days. They will have to take 4 intakes every three hours, the first intake being two hours after waking up.
The study subjects will have to make 2 visits to the laboratory. Physical performance and physiological changes will be evaluated with a 10-minute time trial. The first test will be performed without product consumption and the second after 28 days of consumption.
- Conditions
- Beta Alanine Supplementation
- Being tested
- Beta Alanine high dose, Beta Alanine low dose, Control group
- Keywords
- Chronic effect, Beta Alanine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta Alanine high doseDietary supplement
4 intakes of 5 g of beta alanine every 3 hour.
Beta Alanine low doseDietary supplement
4 intakes of 2.5 g of beta alanine every 3 hour.
Control groupOther
4 intakes of 2.5 g of wheat semolina every 3 hour.
| Study group | Role | What they receive |
|---|---|---|
| Beta Alanine high dose | Experimental | Consumption for 28 days. Receives: Dietary Supplement: Beta Alanine high dose |
| Beta Alanine low dose | Experimental | Consumption for 28 days. Receives: Dietary Supplement: Beta Alanine low dose |
| Control group | Placebo comparator | Consumption for 28 days. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Power
Physical performance is measured by direct variables evaluated by the power roller (average power, maximum power, etc.).
Measured: It will be measured on two different occasions. The first day and twenty-eight days later.
Distance covered
Physical performance is measured by direct variables evaluated by the power roller.
Measured: It will be measured on two different occasions. The first day and twenty-eight days later.
Secondary outcomes (9)
Fatigue
Rate of perceived exertion
Measured: Change of baseline rate of perceived exertion at twenty-eight days
Paresthesia test
Visual analogue scale (1-10)
Measured: It will be measured on two different occasions. on day 1 (before consumption) and twenty-eight days after (after consumption).
Microcapillary blood
This test provides biochemical variables (ABL90FLEX) with 70 ml of capillary blood (Na, K, Glucose, Lactate, etc). It is used to evaluate the effort made by the cyclist.
Measured: It will be measured on two different occasions. Day one and twenty-eight days later.
Lactate
Lactate levels will be measured using the Lactate Pro
Measured: It will be measured on two different occasions. Day one and twenty-eight days later.
Heart Rate
The heart rate will be evaluated by means of a heart rate strap.
Measured: It will be measured on two different occasions. Day one and twenty-eight days later.
Body weight
It is a control variable. Measured by bioimpedance.
Measured: The test will be measured at baseline and after 28 days of consumption.
Fat mass
It is a control variable. Measured by bioimpedance.
Measured: The test will be measured at baseline and after 28 days of consumption.
Muscle mass
It is a control variable. Measured by bioimpedance.
Measured: The test will be measured at baseline and after 28 days of consumption.
Liver safety variables
It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)
Measured: It will be measured twice, once at baseline or at the end of the study after 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start4 Dec 2023
- Primary completion5 Feb 2024
- Study completion11 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
- NCT06191055
- Sponsor's protocol ID
- UCAMCFE-00030
- Acronym
- B-AC2
- 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 Performance in Recreational Cross-country Road Cyclists
- ClinicalTrials.gov ID
- NCT06191055
- Acronym / sponsor ID
- B-AC2 / UCAMCFE-00030
- Conditions
- Beta Alanine Supplementation
- Keywords
- Chronic effect, Beta Alanine
- 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
- 5 Feb 2024 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 5 Jan 2024 (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, single-center, controlled clinical trial with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) to measure the efficacy of 28-day consumption of a sustained-release beta alanine on the physiological efficacy of physical performance in recreational cyclists.
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 28 days. They will have to take 4 intakes every three hours, the first intake being two hours after waking up.
The study subjects will have to make 2 visits to the laboratory. Physical performance and physiological changes will be evaluated with a 10-minute time trial. The first test will be performed without product consumption and the second after 28 days of consumption.
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 28 days. |
| Beta Alanine low dose | Experimental | Dietary Supplement: Beta Alanine low doseConsumption for 28 days. |
| Control group | Placebo comparator | Other: Control groupConsumption for 28 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 dose4 intakes of 5 g of beta alanine every 3 hour. | Dietary supplement | Beta Alanine high dose |
| Beta Alanine low dose4 intakes of 2.5 g of beta alanine every 3 hour. | Dietary supplement | Beta Alanine low dose |
| Control group4 intakes of 2.5 g of wheat semolina every 3 hour. | Other | Control group |
Primary outcome
Power
Time frame: It will be measured on two different occasions. The first day and twenty-eight days later.
Physical performance is measured by direct variables evaluated by the power roller (average power, maximum power, etc.).
Distance covered
Time frame: It will be measured on two different occasions. The first day and twenty-eight days later.
Physical performance is measured by direct variables evaluated by the power roller.
9 secondary outcomes
Fatigue
Time frame: Change of baseline rate of perceived exertion at twenty-eight days
Paresthesia test
Time frame: It will be measured on two different occasions. on day 1 (before consumption) and twenty-eight days after (after consumption).
Microcapillary blood
Time frame: It will be measured on two different occasions. Day one and twenty-eight days later.
Lactate
Time frame: It will be measured on two different occasions. Day one and twenty-eight days later.
Heart Rate
Time frame: It will be measured on two different occasions. Day one and twenty-eight days later.
Body weight
Time frame: The test will be measured at baseline and after 28 days of consumption.
Fat mass
Time frame: The test will be measured at baseline and after 28 days of consumption.
Muscle mass
Time frame: The test will be measured at baseline and after 28 days of consumption.
Liver safety variables
Time frame: It will be measured twice, once at baseline or at the end of the study after 28 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: It will be measured on two different occasions. The first day and twenty-eight days later.). 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.