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Completed

NCT Number: NCT06180512

Study to Analyze the Efficacy of Acute Intake With a β-alanine Supplement in Recreational Cyclists

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.

Completed

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Key information

Conditions

Beta Alanine Supplementation

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Catholic University of Murcia

Murcia, 30107, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Beta Alanine high dose

Dietary Supplement

4 intakes of 5 g of beta alanine every 1 hour and 15 minutes.

Beta Alanine low dose

Dietary Supplement

4 intakes of 2.5 g of beta alanine every 1 hour and 15 minutes.

Control group

Dietary Supplement

4 intakes of 2.5 g of wheat semolina every 1 hour and 15 minutes.

Primary outcomes

  1. Power

    Time frame: It will be measured on two different occasions. Day one and seven days later with acute consumption of product.

    Physical performance is measured by direct variables evaluated by the power roller (average power, maximum power, etc.).

  2. Distance covered

    Time frame: It will be measured on two different occasions. Day one and seven days later with acute consumption of product.

    Physical performance is measured by direct variables evaluated by the power roller.

Secondary outcomes

  1. Fatigue

    Time frame: Change of baseline rate of perceived exertion at seven days

    Rate of perceived exertion, assessed by the 10-point modified Borg Scale.

  2. Paresthesia test

    Time frame: It will be measured on two different occasions. on day 1 (before consumption) and seven days after (after consumption).

    Visual analogue scale (1-10)

  3. Microcapillary blood

    Time frame: It will be measured on two different occasions. Day one and seven 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.

  4. Lactate

    Time frame: It will be measured on two different occasions. Day one and seven days later.

    Lactate levels will be measured using the Lactate Pro

  5. Heart Rate

    Time frame: It will be measured on two different occasions. Day one and seven days later.

    The heart rate will be evaluated by means of a heart rate strap.

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study 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

Acronym: B-AC1

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Dec 22, 2023
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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