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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-23

Study Completion Date

2024-05-30

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.

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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.

Conditions

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Muscle Soreness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A phase I randomized, 2 arm single blinded feasibility study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Subjects will be masked to which intervention they receive, active study drug or placebo.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Riboflavin

Intervention Type DRUG

Commercially available source of riboflavin capsules

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Riboflavin

Commercially available source of riboflavin capsules

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Riboflavin 100mg capsules Placebo capsule

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes