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

Early Phase 1CompletedNCT05907850

Steven Moore150 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Muscle Soreness

Interventions

RiboflavinDRUG

Commercially available source of riboflavin capsules

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 6 days

Secondary Outcomes

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.

Time frame: Day 7

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.