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

Supplementation Clinical Trial

— ELITE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04427319
• Other study ID #: UCAMCFE-00014
• Status: Completed
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: June 12, 2020

Study information

• Verified date: June 2020
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 12, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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 ß-alanine, wheat, soy, nuts (including peanuts), sesame and its byproducts.

Related Conditions & MeSH terms

• Cyclists
• Supplementation

Intervention

Dietary Supplement:
• ß-alanine
7 days of consumption
• wheat semolina
7 days of consumption

Locations

Country	Name	City	State
Spain	Catholic University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue	Rate of perceived exertion	Change of baseline rate of perceived exertion at seven days
Secondary	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.
Secondary	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.
Secondary	Microcapillary blood	This test provides biochemical variables (ABL90FLEX).	It will be measured on two different occasions. Day one and seven days later.