Safety Analysis of Chronic Intake of a β-alanine Supplement

NCT05334121 | Completed

• 1 other identifier: UCAMCFE-00025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Product Safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Paresthesia test

  Change after 8 weeks of consumption

Study Arms (2)

Product - Beta Alanine

EXPERIMENTAL

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

Control group - Placebo

PLACEBO COMPARATOR

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

Interventions

Beta-alanine DIETARY_SUPPLEMENT

The product will be consumed every day for 4 weeks. Four intakes of 3g each, separated by three hours each, will be carried out.

Product - Beta Alanine

Control product consumption OTHER

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.

Control group - Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

Related Publications (1)

• Maestre-Hernandez AB, Perez-Pinero S, Lopez-Roman FJ, Andreu-Caravaca L, Luque-Rubia AJ, Ramos-Campo DJ, Diaz-Silvestre MJ, Avila-Gandia V. Effect of a sustained-release formulation of beta-alanine on laboratory parameters and paresthesia in recreational trained men: a randomized double-blind placebo-controlled study. Front Nutr. 2023 Sep 12;10:1213105. doi: 10.3389/fnut.2023.1213105. eCollection 2023.

  PMID: 37766731 DERIVED

MeSH Terms

Interventions

beta-Alanine

Intervention Hierarchy (Ancestors)

Alanine; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Fco Javier López Román

  Catholic University of Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2022
• First Posted: April 19, 2022
• Study Start: March 21, 2022
• Primary Completion: April 25, 2022
• Study Completion: May 31, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-03

Locations

ES (1)