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Completed

NCT Number: NCT06214338

Blood Bioavailability of Two Different Doses of a β-alanine Supplement (BIo-β)

The purpose of this study is to To study the blood bioavailability of a sustained-release β-alanine granulated supplement of two different doses (10 g and 20 g).

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Key information

Conditions

Bioavailability

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 will consume 10 g of β-alanine one day by 4 ingestions of 2.5 g separated by 1 hour and 15 min. While on another day 20 g of β-alanine by 4 ingestions of 5 g separated by 1 hour and 15 minutes, with a washout period of 15 days between the two doses. Subsequently, the amino acid levels in blood will be analyzed after the product intake and during a period of 8 hours.

Each day of visit the paresthesias (moment of appearance, intensity and sensations) will be studied at different times.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Men between 18 and 60 years old.
  • Cyclists with more than two years of cycling experience.
  • Bicycle training at least twice a week.

Exclusion criteria

  • Suffer a lasting injury that prevents you from training in the month prior to surgery.
  • Subjects with a chronic illness.
  • Having consumed in the three months prior to the start of the study any β-alanine supplement.
  • Making changes in diet or exercise during the study.
  • Inability to understand the informed consent form.
  • Consumption of other supplements that could alter the results of the study.

Treatment and study plan

Low dose

Dietary Supplement

Consumption of a β-alanine sustained-release supplement, 10 mg by 4 intakes of 2.5, separated by 1 hour and 15 min.

High dose

Dietary Supplement

Consumption of a β-alanine sustained-release supplement, 10 mg by 4 intakes of 5 separated by 1 hour and 15 min.

Primary outcomes

  1. Aminoacids in plasma

    Time frame: After the first intake of the product, samples will be taken at 15, 30, 45, 60 and 75 minutes. After the fourth and last product intake, samples will be taken at 15, 30, 45, 60, 75, 90, 120, 180 and 240 minutes.

    The complete series of amino acids will be analyzed in plasma, after supplement intake, for 8 hours and at various times after product intakes. A bioavailability curve will be developed for each of these samples.

Secondary outcomes

  1. Paresthesia

    Time frame: After the first intake of the product, samples will be taken at 15, 30, 45, 60 and 75 minutes. After the fourth and last product intake, samples will be taken at 15, 30, 45, 60, 75, 90, 120, 180 and 240 minutes.

    It will be recorded by means of a visual analog scale (VAS), drawn with a continuous line of 10 centimeters where the left edge determines "no unusual sensation", translated to 0 in the recording of the data; and on the right edge "more intense sensation", translated to 10.

  2. symptomatology - qualitative question

    Time frame: After the first intake of the product, samples will be taken at 15, 30, 45, 60 and 75 minutes. After the fourth and last product intake, samples will be taken at 15, 30, 45, 60, 75, 90, 120, 180 and 240 minutes.

    They should answer if they have felt at any time after the ingestion of β-alanine any symptomatology such as: prickling, itching, tingling, numbness, chills and pain.

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

Blood Bioavailability of Two Different Doses of a β-alanine Supplement

Acronym: Bio-β

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2024
Registry last updated
May 20, 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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