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

NCT04427319 | Completed DMC

• 1 other identifier: UCAMCFE-00014
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Supplementation; Cyclists

Outcome Measures

Primary Outcomes (1)

• Fatigue

  Rate of perceived exertion

  Change of baseline rate of perceived exertion at seven days

Secondary Outcomes (3)

• Performance outcomes

  It will be measured on two different occasions. Day one and seven days later.

• Paresthesia test

  It will be measured on three different occasions. Twice on day 1 (before and after consumption) and seven days after.

• Microcapillary blood

  It will be measured on two different occasions. Day one and seven days later.

Study Arms (2)

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.

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.

Dietary Supplement: wheat semolina

Interventions

β-alanine DIETARY_SUPPLEMENT

7 days of consumption

Experimental group

wheat semolina DIETARY_SUPPLEMENT

7 days of consumption

Placebo group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

Related Publications (1)

• 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.

  PMID: 39226288 DERIVED

MeSH Terms

Interventions

Flour

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 11, 2020
• Study Start: February 10, 2020
• Primary Completion: March 6, 2020
• Study Completion: June 12, 2020
• Last Updated: July 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)