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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Muscle Soreness

Intervention / Treatment
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* Drug: Riboflavin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A phase I randomized, 2 arm single blinded feasibility study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Riboflavin Group<br>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<br>* Commercially available source of riboflavin capsules<br>* Other names: Riboflavin 100mg capsules;|
| Placebo Comparator: Placebo/Control Group<br>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<br>* Placebo capsule compounded to be similar in appearance to the active intervention<br>* Other names: Placebo capsule;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delayed onset muscle soreness, Ultramarathon