Study to Analyze the Aerobic Performance Efficacy of Chronic Intake With a β-alanine Supplement in Recreational Cyclists (B-AC3)

December 19, 2023 updated by: Francisco Javier López Román, Universidad Católica San Antonio de Murcia

Randomized Clinical Trial to Analyze the Efficacy of Chronic Intake of Different Doses of a β-alanine Supplement on Aerobic Performance in Recreational Long-Distance Road Cyclists

Randomized, controlled, double-blind, double-blind clinical trial, with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) and single-center, to measure the efficacy of a sustained release beta alanine on the aerobic performance efficacy in recreational cyclist

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Subjects meeting the selection criteria will be randomly assigned to each of the study groups (investigational product dose 1 or dose 2, or placebo, depending on the group to which they have been assigned).

The product to be consumed is beta alanine. Participants will consume the product for 30 days. They will have to take 4 intakes every three hours, being the first intake two hours after waking up.

The study subjects will have to make 2 visits to the laboratory. At the first and last visit, their aerobic performance will be evaluated by an incremental test to exhaustion with gas analysis.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30107
        • Recruiting
        • Catholic University of Murcia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male cyclists with more than two years of cycling experience.
  • Perform tests without fatigue.
  • Road bike training at least twice a week.

Exclusion Criteria:

  • Participants with chronic illness.
  • Have a long-term injury that prevents you from training in the previous month.
  • Inability to understand informed consent.
  • Have consumed beta alanine in the three years prior to the start of the study.
  • Consumption of other supplements that may alter performance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Beta Alanine high dose
Consumption for 30 days.
Dietary supplement: Beta Alanine high dose
Subjects should consume 4 intakes of 5 g of beta alanine every 3 hours each day.
Experimental: Beta Alanine low dose
Consumption for 30 days.
Dietary supplement: Beta Alanine low dose
Subjects should consume 4 intakes of 2,5 g of beta alanine every 3 hours each day.
Placebo Comparator: Control group
Consumption for 30 days.
Dietary supplement: Control product
Subjects should consume 4 intakes of 2,5 g of wheat semolina every 3 hours each day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Power
Time Frame: Change in performance after 30 days of product consumption
Measured using a cyclus 2 roller.
Change in performance after 30 days of product consumption
Distance
Time Frame: Change in performance after 30 days of product consumption
Measured using a cyclus 2 roller.
Change in performance after 30 days of product consumption

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anaerobic treshold
Time Frame: It will be measured twice, once at baseline or at the end of the study after 30 days.
Through a stress test with gas analysis
It will be measured twice, once at baseline or at the end of the study after 30 days.
Maximum oxygen consumption
Time Frame: It will be measured twice, once at baseline or at the end of the study after 30 days.
Through a stress test with gas analysis
It will be measured twice, once at baseline or at the end of the study after 30 days.
Aerobic threshold
Time Frame: It will be measured twice, once at baseline or at the end of the study after 30 days.
Through a stress test with gas analysis
It will be measured twice, once at baseline or at the end of the study after 30 days.
Microcapillary blood
Time Frame: It will be measured twice, once at baseline or at the end of the study after 30 days.
This test provides biochemical variables (ABL90FLEX) with 70 ml of capillary blood.
It will be measured twice, once at baseline or at the end of the study after 30 days.
Lactate
Time Frame: It will be measured twice, once at baseline or at the end of the study after 30 days.
Lactate levels will be measured using the Lactate Pro 2
It will be measured twice, once at baseline or at the end of the study after 30 days.
Heart Rate
Time Frame: It will be measured twice, once at baseline or at the end of the study after 30 days.
The heart rate will be evaluated by means of a heart rate strap.
It will be measured twice, once at baseline or at the end of the study after 30 days.
Fatigue
Time Frame: It will be measured twice, once at baseline or at the end of the study after 30 days.
Rate of perceived exertion
It will be measured twice, once at baseline or at the end of the study after 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Católica San Antonio de Murcia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2023

Primary Completion (Estimated)

February 19, 2024

Study Completion (Estimated)

March 29, 2024

Study Registration Dates

First Submitted

December 2, 2023

First Submitted That Met QC Criteria

December 9, 2023

First Posted (Actual)

December 12, 2023

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UCAMCFE-00031

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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