Study to Analyze the Aerobic Performance Efficacy of Chronic Intake With a β-alanine Supplement in Recreational Cyclists

Study Overview
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Brief Summary
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Randomized, controlled, double-blind, double-blind clinical trial, with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) and single-center, to measure the efficacy of a sustained release beta alanine on the aerobic performance efficacy in recreational cyclist

Detailed Description
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Subjects meeting the selection criteria will be randomly assigned to each of the study groups (investigational product dose 1 or dose 2, or placebo, depending on the group to which they have been assigned). The product to be consumed is beta alanine. Participants will consume the product for 30 days. They will have to take 4 intakes every three hours, being the first intake two hours after waking up. The study subjects will have to make 2 visits to the laboratory. At the first and last visit, their aerobic performance will be evaluated by an incremental test to exhaustion with gas analysis.

Official Title
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Randomized Clinical Trial to Analyze the Efficacy of Chronic Intake of Different Doses of a β-alanine Supplement on Aerobic Performance in Recreational Long-Distance Road Cyclists

Conditions
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Beta Alanine Supplementation

Intervention / Treatment
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* Dietary Supplement: Beta Alanine high dose
* Dietary Supplement: Beta Alanine low dose
* Dietary Supplement: Control product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male cyclists with more than two years of cycling experience. Perform tests without fatigue. Road bike training at least twice a week. Exclusion Criteria: Participants with chronic illness. Have a long-term injury that prevents you from training in the previous month. Inability to understand informed consent. Have consumed beta alanine in the three years prior to the start of the study. Consumption of other supplements that may alter performance.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beta Alanine high dose<br>Consumption for 30 days. | Dietary Supplement: Beta Alanine high dose<br>* Subjects should consume 4 intakes of 5 g of beta alanine every 3 hours each day.<br>|
| Experimental: Beta Alanine low dose<br>Consumption for 30 days. | Dietary Supplement: Beta Alanine low dose<br>* Subjects should consume 4 intakes of 2,5 g of beta alanine every 3 hours each day.<br>|
| Placebo Comparator: Control group<br>Consumption for 30 days. | Dietary Supplement: Control product<br>* Subjects should consume 4 intakes of 2,5 g of wheat semolina every 3 hours each day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Power | Measured using a cyclus 2 roller. | Change in performance after 30 days of product consumption | 
| Distance | Measured using a cyclus 2 roller. | Change in performance after 30 days of product consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anaerobic treshold | Through a stress test with gas analysis | It will be measured twice, once at baseline or at the end of the study after 30 days. | 
| Maximum oxygen consumption | Through a stress test with gas analysis | It will be measured twice, once at baseline or at the end of the study after 30 days. | 
| Aerobic threshold | Through a stress test with gas analysis | It will be measured twice, once at baseline or at the end of the study after 30 days. | 
| Microcapillary blood | This test provides biochemical variables (ABL90FLEX) with 70 ml of capillary blood. | It will be measured twice, once at baseline or at the end of the study after 30 days. | 
| Lactate | Lactate levels will be measured using the Lactate Pro 2 | It will be measured twice, once at baseline or at the end of the study after 30 days. | 
| Heart Rate | The heart rate will be evaluated by means of a heart rate strap. | It will be measured twice, once at baseline or at the end of the study after 30 days. | 
| Fatigue | Rate of perceived exertion | It will be measured twice, once at baseline or at the end of the study after 30 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aerobic Performance, Beta Alanine, Supplementation