The Efficacy β-Alanine Supplementation in Performance Outcomes of Road Professional Endurance Cyclists

NCT ID: NCT04427319

Last Updated: 2020-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-10

Study Completion Date

2020-06-12

Brief Summary

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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

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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

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Supplementation Cyclists

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental group

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.

Group Type EXPERIMENTAL

β-alanine

Intervention Type DIETARY_SUPPLEMENT

7 days of consumption

Placebo group

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.

Group Type PLACEBO_COMPARATOR

wheat semolina

Intervention Type DIETARY_SUPPLEMENT

7 days of consumption

Interventions

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β-alanine

7 days of consumption

Intervention Type DIETARY_SUPPLEMENT

wheat semolina

7 days of consumption

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Francisco Javier López Román

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catholic University of Murcia

Murcia, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 39226288 (View on PubMed)

Other Identifiers

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UCAMCFE-00014

Identifier Type: -

Identifier Source: org_study_id

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