ClinicalTrials.gg
CompletedNCT05334121HIPOX-βUpdated Jul 26, 2022

Safety Analysis of Chronic Intake of a β-alanine Supplement

An interventional study of Beta-alanine and Control product consumption in Product Safety, sponsored by Universidad Católica San Antonio de Murcia. Completed at 1 site in Spain. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-26.

Sponsored by Universidad Católica San Antonio de Murcia · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Product Safety
03

In context

Lead sponsor

Universidad Católica San Antonio de Murcia is the lead sponsor of 138 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Dietary supplementBeta-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.

  • OtherControl 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.

06

What researchers measure

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)

    Time frame: Change in hepatic safety after 8 weeks of consumption

Secondary outcomes

  1. Paresthesia test

    Visual analogue scale (1-10)

    Time frame: Change after 8 weeks of consumption

07

Study locations

1 site
  • Catholic University of Murcia
    Murcia, 30107, Spain
08

References and documents

Publications

  • 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. PubMed 37766731 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05334121
Responsible party
Francisco Javier López Román (Principal Investigator, Universidad Católica San Antonio de Murcia) — Principal investigator
First posted
Apr 19, 2022
Start date
Mar 21, 2022
Primary completion
Apr 25, 2022
Completion
May 31, 2022
Last update
Jul 26, 2022

Study contacts

Fco Javier López Román
principal investigator · Catholic University of Murcia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Beta-Alanine

Start the discussion