Effects of Riboflavin in Mitigating Muscle Soreness in Ultra-marathon Athletes

Muscle Soreness Clinical Trial

Official title:

A Randomized Placebo-controlled Trial Investigating the Effects of Riboflavin in Mitigating Muscle Soreness in Ultra-marathon Athletes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05907850
• Other study ID #: HSC20230413H
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 23, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Steven Moore, MD
• Phone: (512) 657-6674
• Email: mooresb[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this project is to investigate the effects of riboflavin, also known as vitamin B2, on preventing delayed onset muscle soreness (DOMS) in ultramarathon athletes through a randomized placebo-controlled study.

Description:

The riboflavin 100 mg capsules will be self-dosed by the participant, one capsule prior to the long stage of the race followed by a second dose at the end of the long stage. Historically, long-stage finish times have ranged between 8 and 24 hours. The placebo will also be dosed as one capsule on the morning of the long stage, prior to the race start, and one capsule at the end of the long stage.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Male or female, aged 18 or over

4. In good general health as evidenced by readiness to participate in an ultramarathon

5. Ability to take oral medication and be willing to adhere to the study regimen

6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening.

Exclusion Criteria:

1. Unable to read or understand English

2. Under 18 years of age

3. Pregnancy or lactation

4. Known allergic reactions to components of the investigational drugs

Related Conditions & MeSH terms

• Muscle Soreness
• Myalgia

Intervention

Drug:
• Riboflavin
Commercially available source of riboflavin capsules
• Placebo
Placebo capsule compounded to be similar in appearance to the active intervention

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Steven Moore	Racing the Planet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle soreness measure for long stage of the ultramarathon	Change in muscle soreness at completion of the long stage (80+ kilometers) of the ultramarathon. Muscle soreness the day following long stage completion. Muscle soreness will be measured using a Likert scale rated from 0 to 10 where 0 indicates no soreness and 10 indicates unbearable pain.	Baseline to 6 days
Secondary	Muscle soreness measure post-race	Muscle soreness the day following long stage completion. Muscle soreness the day following long stage completion. Muscle soreness will be measured using a Likert scale rated from 0 to 10 where 0 indicates no soreness and 10 indicates unbearable pain.	Day 7