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OpenTrials
Completed

NCT Number: NCT04427319

The Efficacy 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).

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Key information

Conditions

Supplementation Cyclists

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

β-Alanine

Dietary Supplement

7 days of consumption

wheat semolina

Dietary Supplement

7 days of consumption

Primary outcomes

  1. Fatigue

    Time frame: Change of baseline rate of perceived exertion at seven days

    Rate of perceived exertion

Secondary outcomes

  1. Performance outcomes

    Time frame: 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.

  2. Paresthesia test

    Time frame: 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)

  3. Microcapillary blood

    Time frame: It will be measured on two different occasions. Day one and seven days later.

    This test provides biochemical variables (ABL90FLEX).

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study 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

Acronym: ELITE

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2020
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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