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

Primary Purpose

Muscle Soreness

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Riboflavin
Placebo
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Soreness focused on measuring Delayed onset muscle soreness, Ultramarathon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at San AntonioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Riboflavin Group

Placebo/Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 8, 2023
Last Updated
July 10, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Racing the Planet
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1. Study Identification

Unique Protocol Identification Number
NCT05907850
Brief Title
Effects of Riboflavin in Mitigating Muscle Soreness in Ultra-marathon Athletes
Official Title
A Randomized Placebo-controlled Trial Investigating the Effects of Riboflavin in Mitigating Muscle Soreness in Ultra-marathon Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 23, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Racing the Planet

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Soreness
Keywords
Delayed onset muscle soreness, Ultramarathon

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Riboflavin Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo/Control Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Riboflavin
Other Intervention Name(s)
Riboflavin 100mg capsules
Intervention Description
Commercially available source of riboflavin capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo capsule
Intervention Description
Placebo capsule compounded to be similar in appearance to the active intervention
Primary Outcome Measure Information:
Title
Muscle soreness measure for long stage of the ultramarathon
Description
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 Outcome Measure Information:
Title
Muscle soreness measure post-race
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Moore, MD
Phone
(512) 657-6674
Email
mooresb@uthscsa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alex Soto
Phone
(210) 567-4292
Email
sotoa6@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Moore, MD
Organizational Affiliation
University of Texas Health Science Center San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Moore, MD
Phone
512-657-6674
Email
mooresb@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Alex Soto
Phone
(210) 567-4292
Email
sotoa6@uthscsa.edu

12. IPD Sharing Statement

Learn more about this trial

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

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