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

Sponsor

Universidad Católica San Antonio de Murcia (Other)

Overall Status

Completed

CT.gov ID

NCT04427319

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Supplementation Cyclists	Dietary Supplement: β-alanine Dietary Supplement: wheat semolina	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 10, 2020

Actual Primary Completion Date :

Mar 6, 2020

Actual Study Completion Date :

Jun 12, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Fatigue [Change of baseline rate of perceived exertion at seven days]
Rate of perceived exertion

Secondary Outcome Measures

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.
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catholic University of Murcia	Murcia		Spain	30107

Sponsors and Collaborators

Universidad Católica San Antonio de Murcia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Francisco Javier López Román, Principal Investigator, Universidad Católica San Antonio de Murcia

ClinicalTrials.gov Identifier:

NCT04427319

Other Study ID Numbers:

UCAMCFE-00014

First Posted:

Jun 11, 2020

Last Update Posted:

Jul 30, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 30, 2020