Safety Analysis of Chronic Intake of a β-alanine Supplement

Study Overview
=================
Brief Summary
-----------------
Single-center, double-blind, placebo-controlled clinical trial with two arms (product and placebo) to analyze the safety of beta-alanine consumption in active people.

Detailed Description
-----------------
After recruitment, subjects will be randomized and assigned to one of the two arms of the study: beta-alanine group or control group (placebo). Subjects must be active people, and will take a dose of 15 g per day of the product for 4 weeks.

Official Title
-----------------
Randomized Clinical Trial to Analyze the Safety of Chronic Intake of a β-alanine Supplement in Active Individuals

Conditions
-----------------
Product Safety

Intervention / Treatment
-----------------
* Dietary Supplement: Beta-alanine
* Other: Control product consumption


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men between 18 and 40 years of age. Physically active people. They must train at least 3 sessions per week. Have been training continuously for at least one year. Exclusion Criteria: Participant suffering from chronic illness. Serious or terminal illness. Suffering from a lasting injury that prevents him/her from training in the month prior to the intervention. Inability to understand the informed consent. Previous experience in the consumption of beta alanine.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Product - Beta Alanine<br>The product will be consumed every day for 4 weeks. Four intakes of 3g each, separated by three hours each, will be carried out. | Dietary Supplement: Beta-alanine<br>* The product will be consumed every day for 4 weeks. Four intakes of 3g each, separated by three hours each, will be carried out.<br>|
| Placebo Comparator: Control group - Placebo<br>The product will be consumed every day for 4 weeks. Four intakes of 3g each, separated by three hours each, will be carried out. | Other: Control product consumption<br>* Product with identical characteristics to the experimental product. The product will be consumed every day for 4 weeks. Four intakes of 3g each, separated by three hours each, will be carried out.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver safety variables | It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L) | Change in hepatic safety after 8 weeks of consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paresthesia test | Visual analogue scale (1-10) | Change after 8 weeks of consumption |