Safety Analysis of Chronic Intake of a β-alanine Supplement

NCT ID: NCT05334121

Last Updated: 2022-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2022-05-31

Brief Summary

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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

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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.

Conditions

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Product Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Beta-alanine

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Control product consumption

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role lead

Responsible Party

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Francisco Javier López Román

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fco Javier López Román

Role: PRINCIPAL_INVESTIGATOR

Catholic University of Murcia

Locations

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Catholic University of Murcia

Murcia, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 37766731 (View on PubMed)

Other Identifiers

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UCAMCFE-00025

Identifier Type: -

Identifier Source: org_study_id

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