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

A Randomized Placebo-controlled Trial Investigating the 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.

Study Overview

• Status: Recruiting
• Conditions: Muscle Soreness
• Intervention / Treatment: Drug: Riboflavin; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 400
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Steven Moore, MD; Phone Number: (512) 657-6674; Email: mooresb@uthscsa.edu
• Study Contact Backup: Name: Stephanie Perez; Phone Number: (210)450-8973; Email: perezs11@uthscsa.edu

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • The University of Texas Health Science Center at San Antonio
      • Contact: Steven Moore, MD; Phone Number: 512-657-6674; Email: mooresb@uthscsa.edu
      • Contact: Stephanie Perez; Phone Number: (210) 450-8973; Email: perezs11@uthscsa.edu

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Riboflavin Group; 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.	Drug: Riboflavin; Commercially available source of riboflavin capsules; Other Names: Riboflavin 100mg capsules
Placebo Comparator: Placebo/Control Group; 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.	Drug: Placebo; Placebo capsule compounded to be similar in appearance to the active intervention; Other Names: Placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Steven Moore
• Collaborators: Racing the Planet
• Investigators: Principal Investigator: Steven Moore, MD, University of Texas Health Science Center San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 8, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Delayed onset muscle soreness; Ultramarathon
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia; Physiological Effects of Drugs; Photosensitizing Agents; Dermatologic Agents; Micronutrients; Vitamins; Vitamin B Complex; Riboflavin
• Other Study ID Numbers: HSC20230413H

Drug and device information, study documents

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