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Completed

NCT Number: NCT06191055

Study to Analyze the Efficacy of Chronic Intake With a β-alanine Supplement in Recreational 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.

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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 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.

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 3 hour.

Beta Alanine low dose

Dietary Supplement

4 intakes of 2.5 g of beta alanine every 3 hour.

Control Group

Other

4 intakes of 2.5 g of wheat semolina every 3 hour.

Primary outcomes

  1. 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.).

  2. 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

  1. Fatigue

    Time frame: Change of baseline rate of perceived exertion at twenty-eight days

    Rate of perceived exertion

  2. 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)

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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)

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 Chronic Intake of Different Doses of a β-alanine Supplement on Performance in Recreational Cross-country Road Cyclists

Acronym: B-AC2

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 5, 2024
Registry last updated
May 17, 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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