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

NCT06214338 | Completed DMC

• 1 other identifier: UCAMCFE-00035
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Bioavailability

Keywords

β-alanine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Paresthesia

  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

  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.

Study Arms (2)

Low Dose

EXPERIMENTAL

10 mg of β-alanine

Dietary Supplement: Low dose

High Dose

EXPERIMENTAL

20 mg of β-alanine

Dietary Supplement: High dose

Interventions

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.

Low Dose

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.

High Dose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

MeSH Terms

Interventions

Contraceptives, Oral

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 19, 2024
• Study Start: February 12, 2024
• Primary Completion: March 18, 2024
• Study Completion: April 15, 2024
• Last Updated: May 20, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)