Study to Analyze the Efficacy of Chronic Intake With a β-alanine Supplement in Recreational Cyclists (B-AC2)

May 17, 2024 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 Performance in Recreational Cross-country Road Cyclists

Randomized, controlled, double-blind, single-center, controlled clinical trial with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) to measure the efficacy of 28-day consumption of a sustained-release beta alanine on the physiological efficacy of physical performance in recreational cyclists.

Study Overview

Status

Completed

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 28 days. They will have to take 4 intakes every three hours, the first intake being two hours after waking up.

The study subjects will have to make 2 visits to the laboratory. Physical performance and physiological changes will be evaluated with a 10-minute time trial. The first test will be performed without product consumption and the second after 28 days of consumption.

Study Type

Interventional

Enrollment (Actual)

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
        • Catholic University of Murcia

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 28 days.
Dietary supplement: Beta Alanine high dose
4 intakes of 5 g of beta alanine every 3 hour.
Experimental: Beta Alanine low dose
Consumption for 28 days.
Dietary supplement: Beta Alanine low dose
4 intakes of 2.5 g of beta alanine every 3 hour.
Placebo Comparator: Control group
Consumption for 28 days.
Other: Control group
4 intakes of 2.5 g of wheat semolina every 3 hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Power
Time Frame: It will be measured on two different occasions. The first day and twenty-eight days later.
Physical performance is measured by direct variables evaluated by the power roller (average power, maximum power, etc.).
It will be measured on two different occasions. The first day and twenty-eight days later.
Distance covered
Time Frame: It will be measured on two different occasions. The first day and twenty-eight days later.
Physical performance is measured by direct variables evaluated by the power roller.
It will be measured on two different occasions. The first day and twenty-eight days later.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue
Time Frame: Change of baseline rate of perceived exertion at twenty-eight days
Rate of perceived exertion
Change of baseline rate of perceived exertion at twenty-eight days
Paresthesia test
Time Frame: It will be measured on two different occasions. on day 1 (before consumption) and twenty-eight days after (after consumption).
Visual analogue scale (1-10)
It will be measured on two different occasions. on day 1 (before consumption) and twenty-eight days after (after consumption).
Microcapillary blood
Time Frame: It will be measured on two different occasions. Day one and twenty-eight days later.
This test provides biochemical variables (ABL90FLEX) with 70 ml of capillary blood (Na, K, Glucose, Lactate, etc). It is used to evaluate the effort made by the cyclist.
It will be measured on two different occasions. Day one and twenty-eight days later.
Lactate
Time Frame: It will be measured on two different occasions. Day one and twenty-eight days later.
Lactate levels will be measured using the Lactate Pro
It will be measured on two different occasions. Day one and twenty-eight days later.
Heart Rate
Time Frame: It will be measured on two different occasions. Day one and twenty-eight days later.
The heart rate will be evaluated by means of a heart rate strap.
It will be measured on two different occasions. Day one and twenty-eight days later.
Body weight
Time Frame: The test will be measured at baseline and after 28 days of consumption.
It is a control variable. Measured by bioimpedance.
The test will be measured at baseline and after 28 days of consumption.
Fat mass
Time Frame: The test will be measured at baseline and after 28 days of consumption.
It is a control variable. Measured by bioimpedance.
The test will be measured at baseline and after 28 days of consumption.
Muscle mass
Time Frame: The test will be measured at baseline and after 28 days of consumption.
It is a control variable. Measured by bioimpedance.
The test will be measured at baseline and after 28 days of consumption.
Liver safety variables
Time Frame: It will be measured twice, once at baseline or at the end of the study after 28 days.
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)
It will be measured twice, once at baseline or at the end of the study after 28 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 (Actual)

February 5, 2024

Study Completion (Actual)

March 11, 2024

Study Registration Dates

First Submitted

December 2, 2023

First Submitted That Met QC Criteria

December 19, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UCAMCFE-00030

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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