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

Sponsor

The University of Texas Health Science Center at San Antonio (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05907850

Collaborator

Racing the Planet (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Muscle Soreness	Drug: Riboflavin Drug: Placebo	Early Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A phase I randomized, 2 arm single blinded feasibility studyA phase I randomized, 2 arm single blinded feasibility study

Masking:

Single (Participant)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Muscle soreness measure for long stage of the ultramarathon [Baseline to 6 days]
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.

Secondary Outcome Measures

Muscle soreness measure post-race [Day 7]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio
Racing the Planet

Investigators

Principal Investigator: Steven Moore, MD, University of Texas Health Science Center San Antonio

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The University of Texas Health Science Center at San Antonio

ClinicalTrials.gov Identifier:

NCT05907850

Other Study ID Numbers:

HSC20230413H

First Posted:

Jun 18, 2023

Last Update Posted:

Jun 18, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The University of Texas Health Science Center at San Antonio

Delayed onset muscle soreness

Ultramarathon

Additional relevant MeSH terms:

Myalgia

Riboflavin

Study Results

No Results Posted as of Jun 18, 2023