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

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

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).

Study Overview

• Status: Completed
• Conditions: Bioavailability
• Intervention / Treatment: Dietary supplement: Low dose; Dietary supplement: High dose

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Dose; 10 mg of β-alanine	Dietary supplement: Low dose; Consumption of a β-alanine sustained-release supplement, 10 mg by 4 intakes of 2.5, separated by 1 hour and 15 min.
Experimental: High Dose; 20 mg of β-alanine	Dietary supplement: High dose; Consumption of a β-alanine sustained-release supplement, 10 mg by 4 intakes of 5 separated by 1 hour and 15 min.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
symptomatology - qualitative question	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.	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.

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2024
• Primary Completion (Actual): March 18, 2024
• Study Completion (Actual): April 15, 2024

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: β-alanine
• Other Study ID Numbers: UCAMCFE-00035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No