Study to Analyze the Efficacy of Acute 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, single-center, double-blind clinical trial with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) to measure the efficacy of a sustained release beta alanine on physiological physical performance efficacy in recreational cyclists.

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 1 day. They will have to take four intakes every hour and a quarter, on the same day. The study subjects will have to make 2 visits to the laboratory. In the first one, they will have to perform a 10-minute time trial, without consumption. In the second visit, they will perform the same performance test but with acute consumption of the product. Their physical and physiological performance will be evaluated. The two tests will be separated by 7 days.

Official Title
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Randomized Clinical Trial to Analyze the Efficacy of Acute Intake of Different Doses of a β-alanine Supplement on Performance in Recreational Cross-country 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 group


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 1 day. | Dietary Supplement: Beta Alanine high dose<br>* 4 intakes of 5 g of beta alanine every 1 hour and 15 minutes.<br>|
| Experimental: Beta Alanine low dose<br>Consumption for 1 day. | Dietary Supplement: Beta Alanine low dose<br>* 4 intakes of 2.5 g of beta alanine every 1 hour and 15 minutes.<br>|
| Placebo Comparator: Control group<br>Consumption for 1 day. | Dietary Supplement: Control group<br>* 4 intakes of 2.5 g of wheat semolina every 1 hour and 15 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Power | Physical performance is measured by direct variables evaluated by the power roller (average power, maximum power, etc.). | It will be measured on two different occasions. Day one and seven days later with acute consumption of product. | 
| Distance covered | Physical performance is measured by direct variables evaluated by the power roller. | It will be measured on two different occasions. Day one and seven days later with acute consumption of product. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Rate of perceived exertion, assessed by the 10-point modified Borg Scale. | Change of baseline rate of perceived exertion at seven days | 
| Paresthesia test | Visual analogue scale (1-10) | It will be measured on two different occasions. on day 1 (before consumption) and seven days after (after consumption). | 
| Microcapillary blood | This test provides biochemical variables (ABL90FLEX) with 70 ml of capillary blood (Na, K, Glucose, Lactate, etc). It is used to evaluate the effort made by the cyclist. | It will be measured on two different occasions. Day one and seven days later. | 
| Lactate | Lactate levels will be measured using the Lactate Pro | It will be measured on two different occasions. Day one and seven days later. | 
| Heart Rate | The heart rate will be evaluated by means of a heart rate strap. | It will be measured on two different occasions. Day one and seven days later. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute effect, Beta Alanine