Clinical trial NCT06180512: Study to Analyze the Efficacy of Acute Intake With a β-alanine Supplement in Recreational Cyclists
Official title: Randomized Clinical Trial to Analyze the Efficacy of Acute 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: Acute effect
Beta Alanine
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2023-12-22
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, double-blind 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 a sustained release beta alanine on physiological physical performance efficacy 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 1 day. They will have to take four intakes every hour and a quarter, on the same day.

The study subjects will have to make 2 visits to the laboratory. In the first one, they will have to perform a 10-minute time trial, without consumption. In the second visit, they will perform the same performance test but with acute consumption of the product. Their physical and physiological performance will be evaluated.

The two tests will be separated by 7 days.

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. Day one and seven days later with acute consumption of product.
measure: Distance covered
timeFrame: It will be measured on two different occasions. Day one and seven days later with acute consumption of product.
Secondary outcomes:
measure: Fatigue
timeFrame: Change of baseline rate of perceived exertion at seven days
measure: Paresthesia test
timeFrame: It will be measured on two different occasions. on day 1 (before consumption) and seven days after (after consumption).
measure: Microcapillary blood
timeFrame: It will be measured on two different occasions. Day one and seven days later.
measure: Lactate
timeFrame: It will be measured on two different occasions. Day one and seven days later.
measure: Heart Rate
timeFrame: It will be measured on two different occasions. Day one and seven days later.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References: