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

Universidad Católica San Antonio de Murcia

Status: Completed

Conditions: Supplementation; Cyclists

Treatments: Dietary Supplement: wheat semolina; Dietary Supplement: β-alanine

Study type: Interventional

Funder types: Other

Identifiers

NCT04427319

UCAMCFE-00014

Details and patient eligibility

About

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).

Full 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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: β-alanine

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: wheat semolina