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

Bioavailability Clinical Trial

— Bio-ß  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06214338
• Other study ID #: UCAMCFE-00035
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: April 15, 2024

Study information

• Verified date: December 2023
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: April 15, 2024
• Est. primary completion date: March 18, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Bioavailability

Intervention

Dietary Supplement:
• Low dose
Consumption of a ß-alanine sustained-release supplement, 10 mg by 4 intakes of 2.5, separated by 1 hour and 15 min.
• High dose
Consumption of a ß-alanine sustained-release supplement, 10 mg by 4 intakes of 5 separated by 1 hour and 15 min.

Locations

Country	Name	City	State
Spain	Catholic University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aminoacids in plasma	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.	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.
Secondary	Paresthesia	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.	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.
Secondary	symptomatology - qualitative question	They should answer if they have felt at any time after the ingestion of ß-alanine any symptomatology such as: prickling, itching, tingling, numbness, chills and pain.	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.