SupplementationELITENCT04427319
The Efficacy β-Alanine Supplementation in Performance Outcomes of Road Professional Endurance Cyclists
A study testing β-alanine and wheat semolina in people with Supplementation and Cyclists, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
A double-blind, placebo-controlled, randomised, with two arms (product and placebo) unicentric clinical trial to analyse the efficacy on physical performance parameters of a product designed for sport during a lapse of two weeks (7 days). Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Supplementation, Cyclists
- What is being tested?
- β-alanine and wheat semolina
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2020to 12 Jun 2020
- 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 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Not respecting rest the day before physical tests.
- Not being in a fasted state (at least 2 h from last meal).
- Having consumed stimulants acutely before the trial, or under drug treatment affecting perceived effort of the trial.
- Not being available to perform every trial on the same conditions at the same time of the day.
- Not sticking to the same diet, 24 h before each trial.
Who cannot join
- Adverse event
- Protocol violation
- Lost to follow-up
- Allergy to any of the components of the treatment or placebo product. This includes allergy to β-alanine, wheat, soy, nuts (including peanuts), sesame and its byproducts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Double-blind Clinical Trial to Analyse the Efficacy of Short-term β-Alanine Supplementation in Performance Outcomes of Road Professional Endurance Cyclists
A double-blind, placebo-controlled, randomised, with two arms (product and placebo) unicentric clinical trial to analyse the efficacy on physical performance parameters of a product designed for sport during a lapse of two weeks (7 days).
Read the detailed description
After recruitment, subject will be randomised and allocated to one group of the 2 study arms: treatment group or control group (placebo).
A simple randomisation will be performed using software by a random number generator, and assigned to participants.
- Conditions
- Supplementation, Cyclists
- Being tested
- β-alanine, wheat semolina
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
β-alanineDietary supplement
7 days of consumption
wheat semolinaDietary supplement
7 days of consumption
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Product: β-Alanine Supplementation strategy: 5 g, four times a day with main meals, for 7 days after the initial evaluation and until the end of the study. Receives: Dietary Supplement: β-alanine |
| Placebo group | Placebo comparator | Product: wheat semolina Supplementation strategy: 5 g, four times a day with main meals, for 7 days after the initial evaluation and until the end of the study. Receives: Dietary Supplement: wheat semolina |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue
Rate of perceived exertion
Measured: Change of baseline rate of perceived exertion at seven days
Secondary outcomes (3)
Performance outcomes
Physical performance is measured by direct variables: mean power output (MPO) and peak power output by ergometer (Cyclus 2) together with cadence.
Measured: It will be measured on two different occasions. Day one and seven days later.
Paresthesia test
Visual analogue scale (1-10)
Measured: It will be measured on three different occasions. Twice on day 1 (before and after consumption) and seven days after.
Microcapillary blood
This test provides biochemical variables (ABL90FLEX).
Measured: It will be measured on two different occasions. Day one and seven days later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start10 Feb 2020
- Primary completion6 Mar 2020
- Study completion12 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 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
- NCT04427319
- Sponsor's protocol ID
- UCAMCFE-00014
- Acronym
- ELITE
- Status last verified
- Jun 2020
- First submitted
- 3 Jun 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perez-Pinero S, Ramos-Campo DJ, Lopez-Roman FJ, Ortolano R, Torregrosa-Garcia A, Luque-Rubia AJ, Ibanez-Soroa N, Andreu-Caravaca L, Avila-Gandia V. Effect of high-dose beta-Alanine supplementation on uphill cycling performance in World Tour cyclists: A randomised controlled trial. PLoS One. 2024 Sep 3;19(9):e0309404. doi: 10.1371/journal.pone.0309404. eCollection 2024.
PubMed 39226288
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double-blind Clinical Trial to Analyse the Efficacy of Short-term β-Alanine Supplementation in Performance Outcomes of Road Professional Endurance Cyclists
- ClinicalTrials.gov ID
- NCT04427319
- Acronym / sponsor ID
- ELITE / UCAMCFE-00014
- Conditions
- Supplementation, Cyclists
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 11 Jun 2020 (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.
A double-blind, placebo-controlled, randomised, with two arms (product and placebo) unicentric clinical trial to analyse the efficacy on physical performance parameters of a product designed for sport during a lapse of two weeks (7 days).
Detailed description
After recruitment, subject will be randomised and allocated to one group of the 2 study arms: treatment group or control group (placebo).
A simple randomisation will be performed using software by a random number generator, and assigned to participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: β-alanineProduct: β-Alanine Supplementation strategy: 5 g, four times a day with main meals, for 7 days after the initial evaluation and until the end of the study. |
| Placebo group | Placebo comparator | Dietary Supplement: wheat semolinaProduct: wheat semolina Supplementation strategy: 5 g, four times a day with main meals, for 7 days after the initial evaluation and until the end of the study. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Not respecting rest the day before physical tests.
- Not being in a fasted state (at least 2 h from last meal).
- Having consumed stimulants acutely before the trial, or under drug treatment affecting perceived effort of the trial.
- Not being available to perform every trial on the same conditions at the same time of the day.
- Not sticking to the same diet, 24 h before each trial.
Key exclusion criteria (4 listed)
- Adverse event
- Protocol violation
- Lost to follow-up
- Allergy to any of the components of the treatment or placebo product. This includes allergy to β-alanine, wheat, soy, nuts (including peanuts), sesame and its byproducts.
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 |
|---|---|---|
| β-alanine7 days of consumption | Dietary supplement | Experimental group |
| wheat semolina7 days of consumption | Dietary supplement | Placebo group |
Primary outcome
Fatigue
Time frame: Change of baseline rate of perceived exertion at seven days
Rate of perceived exertion
3 secondary outcomes
Performance outcomes
Time frame: It will be measured on two different occasions. Day one and seven days later.
Paresthesia test
Time frame: It will be measured on three different occasions. Twice on day 1 (before and after consumption) and seven days after.
Microcapillary blood
Time frame: It will be measured on two different occasions. Day one and seven days later.
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 Jul 2020.
- Derived from this study: PubMed 39226288Perez-Pinero S, Ramos-Campo DJ, Lopez-Roman FJ, Ortolano R, Torregrosa-Garcia A, Luque-Rubia AJ, Ibanez-Soroa N, Andreu-Caravaca L, Avila-Gandia V. Effect of high-dose beta-Alanine supplementation on uphill cycling performance in World Tour cyclists: A randomised controlled trial. PLoS One. 2024 Sep 3;19(9):e0309404. doi: 10.1371/journal.pone.0309404. eCollection 2024.
- Individual participant dataSharing planned: No
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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 β-alanine and wheat semolina in people with Supplementation and Cyclists, 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 5 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: finished, as of the sponsor's last update on 30 Jul 2020. 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?
Fatigue (time frame: Change of baseline rate of perceived exertion at seven days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04427319, which also lists 1 linked publication.
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 Jul 2020.