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

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).

Study Overview

• Status: Completed
• Conditions: Supplementation; Cyclists
• Intervention / Treatment: Dietary supplement: β-alanine; Dietary supplement: wheat semolina

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: β-alanine; 7 days of consumption
Placebo Comparator: 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.	Dietary supplement: wheat semolina; 7 days of consumption

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	Rate of perceived exertion	Change of baseline rate of perceived exertion at seven days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance outcomes	Physical performance is measured by direct variables: mean power output (MPO) and peak power output by ergometer (Cyclus 2) together with cadence.	It will be measured on two different occasions. Day one and seven days later.
Paresthesia test	Visual analogue scale (1-10)	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).	It will be measured on two different occasions. Day one and seven days later.

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Actual): March 6, 2020
• Study Completion (Actual): June 12, 2020

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: UCAMCFE-00014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No