Safety Analysis of Chronic Intake of a β-alanine Supplement (HIPOX-β)

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

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.

Study Overview

• Status: Completed
• Conditions: Product Safety
• Intervention / Treatment: Dietary supplement: Beta-alanine; Other: Control product consumption

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Product - 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.	Dietary supplement: 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.
Placebo Comparator: Control group - Placebo; 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; 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.

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

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia
• Investigators: Principal Investigator: Fco Javier López Román, Catholic University of Murcia

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Actual): April 25, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: March 26, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: UCAMCFE-00025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No