Muscle Soreness
Conditions
Keywords
Delayed onset muscle soreness, Ultramarathon
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.
Interventions
DRUGRiboflavin
Commercially available source of riboflavin capsules
DRUGPlacebo
Placebo capsule compounded to be similar in appearance to the active intervention
Sponsors
Racing the Planet
Steven Moore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Subjects will be masked to which intervention they receive, active study drug or placebo.
Intervention model description
A phase I randomized, 2 arm single blinded feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed