Clinical trial NCT06191055: Study to Analyze the Efficacy of Chronic Intake With a β-alanine Supplement in Recreational Cyclists
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Beta Alanine Supplementation
Keywords: Chronic effect
Beta Alanine
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 75
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Power
timeFrame: It will be measured on two different occasions. The first day and twenty-eight days later.
measure: Distance covered
timeFrame: It will be measured on two different occasions. The first day and twenty-eight days later.
Secondary outcomes:
measure: Fatigue
timeFrame: Change of baseline rate of perceived exertion at twenty-eight days
measure: Paresthesia test
timeFrame: It will be measured on two different occasions. on day 1 (before consumption) and twenty-eight days after (after consumption).
measure: Microcapillary blood
timeFrame: It will be measured on two different occasions. Day one and twenty-eight days later.
measure: Lactate
timeFrame: It will be measured on two different occasions. Day one and twenty-eight days later.
measure: Heart Rate
timeFrame: It will be measured on two different occasions. Day one and twenty-eight days later.
measure: Body weight
timeFrame: The test will be measured at baseline and after 28 days of consumption.
measure: Fat mass
timeFrame: The test will be measured at baseline and after 28 days of consumption.
measure: Muscle mass
timeFrame: The test will be measured at baseline and after 28 days of consumption.
measure: Liver safety variables
timeFrame: It will be measured twice, once at baseline or at the end of the study after 28 days.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References: