Safety Analysis of Chronic Intake of a β-alanine Supplement

Not Applicable

Completed

• Conditions: Product Safety
• Interventions: Dietary Supplement: Beta-alanine; Other: Control product consumption

• Registration Number: NCT05334121
• Lead Sponsor: Universidad Católica San Antonio de Murcia

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.

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-21
• Study First Submitted: 2022-03-26
• Study First Submitted QC: 2022-04-11
• Study First Posted: 2022-04-19
• Primary Completion: 2022-04-25
• Study Completion: 2022-05-31
• Last Update Submitted: 2022-07-24
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Product - Beta Alanine	Beta-alanine	The product will be consumed every day for 4 weeks. Four intakes of 3g each, separated by three hours each, will be carried out.
Control group - Placebo	Control product consumption	The product will be consumed every day for 4 weeks. Four intakes of 3g each, separated by three hours each, will be carried out.

Primary Outcome Measures

Name	Time	Method
Liver safety variables	Change in hepatic safety after 8 weeks of consumption	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)

Secondary Outcome Measures

Name	Time	Method
Paresthesia test	Change after 8 weeks of consumption	Visual analogue scale (1-10)

Trial Locations

Locations (1)

Catholic University of Murcia; 🇪🇸 Murcia, Spain