Muscle SorenessEarly Phase 1NCT05907850
Effects of Riboflavin in Mitigating Muscle Soreness in Ultra-marathon Athletes
A Early Phase 1 study testing Riboflavin in people with Muscle Soreness, run by Steven Moore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Soreness
- What is being tested?
- Riboflavin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2023to 30 May 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unable to read or understand English
- Under 18 years of age
- Pregnancy or lactation
- Known allergic reactions to components of the investigational drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Randomized Placebo-controlled Trial Investigating the Effects of Riboflavin in Mitigating Muscle Soreness in Ultra-marathon Athletes
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.
Read the 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.
- Conditions
- Muscle Soreness
- Being tested
- Riboflavin, Placebo
- Keywords
- Delayed onset muscle soreness, Ultramarathon
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiboflavinDrug
Also called Riboflavin 100mg capsules
Commercially available source of riboflavin capsules
PlaceboDrug
Also called Placebo capsule
Placebo capsule compounded to be similar in appearance to the active intervention
| Study group | Role | What they receive |
|---|---|---|
| Riboflavin Group | Active comparator | 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. Receives: Drug: Riboflavin |
| Placebo/Control Group | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 days
Secondary outcomes (1)
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.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start23 Jun 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SorenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A phase I randomized, 2 arm single blinded feasibility study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steven Moore
- Sponsor type
- University, hospital or other
- Collaborators
- Racing the Planet
- Responsible party
- Sponsor-investigator, Steven Moore, The University of Texas Health Science Center at San Antonio
- Investigators
- Steven Moore, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907850
- Sponsor's protocol ID
- HSC20230413H
- Status last verified
- Mar 2025
- First submitted
- 8 Jun 2023
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Placebo-controlled Trial Investigating the Effects of Riboflavin in Mitigating Muscle Soreness in Ultra-marathon Athletes
- ClinicalTrials.gov ID
- NCT05907850
- Acronym / sponsor ID
- HSC20230413H
- Conditions
- Muscle Soreness
- Keywords
- Delayed onset muscle soreness, Ultramarathon
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Steven MooreUniversity, hospital or other
- Collaborators
- Racing the Planet
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A phase I randomized, 2 arm single blinded feasibility study
| Arm | Type | Receives |
|---|---|---|
| Riboflavin Group | Active comparator | Drug: RiboflavinRiboflavin 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/Control Group | Placebo comparator | Drug: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Unable to read or understand English
- Under 18 years of age
- Pregnancy or lactation
- Known allergic reactions to components of the investigational drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RiboflavinAlso: Riboflavin 100mg capsulesCommercially available source of riboflavin capsules | Drug | Riboflavin Group |
| PlaceboAlso: Placebo capsulePlacebo capsule compounded to be similar in appearance to the active intervention | Drug | Placebo/Control Group |
Primary outcome
Muscle soreness measure for long stage of the ultramarathon
Time frame: 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.
1 secondary outcome
Muscle soreness measure post-race
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Moore, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Riboflavin in people with Muscle Soreness, run by Steven Moore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle soreness measure for long stage of the ultramarathon (time frame: Baseline to 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.