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

Purpose

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.

Condition

  • Muscle Soreness

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
A phase I randomized, 2 arm single blinded feasibility study
Primary Purpose
Treatment
Masking
Single (Participant)
Masking Description
Subjects will be masked to which intervention they receive, active study drug or placebo.

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

The University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
Steven Moore, MD
512-657-6674
mooresb@uthscsa.edu

More Details

Status
Recruiting
Sponsor
Steven Moore

Study Contact

Steven Moore, MD
(512) 657-6674
mooresb@uthscsa.edu

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.