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Clinical Trials/NCT06191055
NCT06191055
Completed
Not Applicable

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

Universidad Católica San Antonio de Murcia1 site in 1 country75 target enrollmentDecember 4, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Beta Alanine Supplementation
Sponsor
Universidad Católica San Antonio de Murcia
Enrollment
75
Locations
1
Primary Endpoint
Power
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
December 4, 2023
End Date
March 11, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Universidad Católica San Antonio de Murcia
Responsible Party
Principal Investigator
Principal Investigator

Francisco Javier López Román

Principal Investigator

Universidad Católica San Antonio de Murcia

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.).

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.

Secondary Outcomes

  • Fatigue(Change of baseline rate of perceived exertion at twenty-eight days)
  • Microcapillary blood(It will be measured on two different occasions. Day one and twenty-eight days later.)
  • Body weight(The test will be measured at baseline and after 28 days of consumption.)
  • Muscle mass(The test will be measured at baseline and after 28 days of consumption.)
  • Fat mass(The test will be measured at baseline and after 28 days of consumption.)
  • Paresthesia test(It will be measured on two different occasions. on day 1 (before consumption) and twenty-eight days after (after consumption).)
  • Lactate(It will be measured on two different occasions. Day one and twenty-eight days later.)
  • Heart Rate(It will be measured on two different occasions. Day one and twenty-eight days later.)
  • Liver safety variables(It will be measured twice, once at baseline or at the end of the study after 28 days.)

Study Sites (1)

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