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

Early Phase 1

Recruiting

• Conditions: Muscle Soreness
• Interventions: Drug: Placebo; Drug: Riboflavin

• Registration Number: NCT05907850
• Lead Sponsor: Steven Moore

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-06-08
• Study First Submitted QC: 2023-06-08
• Study First Posted: 2023-06-18
• Study Start: 2023-06-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo/Control Group	Placebo	Placebo will be self administered by participants, one capsule prior to the long stage of the race followed by a second dose at the completion of the long stage.
Riboflavin Group	Riboflavin	Riboflavin 100mg will be self administered by participants, one capsules prior to the long stage of the race followed by a second dose at the completion of the long stage.

Primary Outcome Measures

Name	Time	Method
Muscle soreness measure for long stage of the ultramarathon	Baseline to 6 days	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.

Secondary Outcome Measures

Name	Time	Method
Muscle soreness measure post-race	Day 7	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.

Trial Locations

Locations (1)

The University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States