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

NCT05907850 | Completed Early Phase 1 FDA Drug

• 1 other identifier: HSC20230413H
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Soreness

Keywords

Delayed onset muscle soreness; Ultramarathon

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Muscle soreness measure post-race

  Day 7

Study Arms (2)

Riboflavin Group

ACTIVE COMPARATOR

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

Placebo/Control Group

PLACEBO COMPARATOR

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

Interventions

Riboflavin DRUG

Commercially available source of riboflavin capsules

Also known as: Riboflavin 100mg capsules

Riboflavin Group

Placebo DRUG

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

Also known as: Placebo capsule

Placebo/Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Steven Moore: lead
• Racing the Planet: collaborator

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Myalgia

Interventions

Riboflavin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors

Study Officials

• Steven Moore, MD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be masked to which intervention they receive, active study drug or placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: A phase I randomized, 2 arm single blinded feasibility study

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: June 23, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

US (1)