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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Randomised Double-blind Clinical Trial to Analyse the Efficacy of Short-term β-Alanine Supplementation in Performance Outcomes of Road Professional Endurance Cyclists

Conditions
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Supplementation, Cyclists

Intervention / Treatment
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* Dietary Supplement: β-alanine
* Dietary Supplement: wheat semolina


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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<br>* 7 days of consumption<br>|
| Placebo Comparator: Placebo group<br>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<br>* 7 days of consumption<br>|

What is the study measuring?
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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. |