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OpenTrials
Completed

NCT Number: NCT05907850

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

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.

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Key information

Conditions

Muscle Soreness Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 18 or over
  • In good general health as evidenced by readiness to participate in an ultramarathon
  • Ability to take oral medication and be willing to adhere to the study regimen
  • For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening.

Exclusion criteria

  • Unable to read or understand English
  • Under 18 years of age
  • Pregnancy or lactation
  • Known allergic reactions to components of the investigational drugs

Treatment and study plan

Riboflavin

Drug

Commercially available source of riboflavin capsules

Other names: Riboflavin 100mg capsules

Placebo

Drug

Placebo capsule compounded to be similar in appearance to the active intervention

Other names: Placebo capsule

Primary outcomes

  1. Muscle soreness measure for long stage of the ultramarathon

    Time frame: 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 outcomes

  1. Muscle soreness measure post-race

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Steven Moore

Other

Collaborators

  • Racing the Planet

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 18, 2023
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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