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

Not Applicable

Completed

• Conditions: Supplementation; Cyclists
• Interventions: Dietary Supplement: β-alanine; Dietary Supplement: wheat semolina

• Registration Number: NCT04427319
• Lead Sponsor: Universidad Católica San Antonio de Murcia

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).

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 Timeline

• Study Start: 2020-02-10
• Primary Completion: 2020-03-06
• Status Verified: 2020-06
• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Completion: 2020-06-12
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	β-alanine	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.
Placebo group	wheat semolina	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.

Primary Outcome Measures

Name	Time	Method
Fatigue	Change of baseline rate of perceived exertion at seven days	Rate of perceived exertion

Secondary Outcome Measures

Name	Time	Method
Paresthesia test	It will be measured on three different occasions. Twice on day 1 (before and after consumption) and seven days after.	Visual analogue scale (1-10)
Microcapillary blood	It will be measured on two different occasions. Day one and seven days later.	This test provides biochemical variables (ABL90FLEX).
Performance outcomes	It will be measured on two different occasions. Day one and seven days later.	Physical performance is measured by direct variables: mean power output (MPO) and peak power output by ergometer (Cyclus 2) together with cadence.

Trial Locations

Locations (1)

Catholic University of Murcia; 🇪🇸 Murcia, Spain