Concussion, MildTRMC-004NCT02721537
Use of 31P MRS to Assess Brain NAD+ in Healthy Current and Former Collegiate Athletes
A study testing Nicotinamide Riboside in people with Concussion, Mild, run by Mayo Clinic at 2 sites in United States.
Trial summary
Can nicotinamide riboside (750 mg/day for 12 weeks) affect the levels of NAD+ in the brain as measured by 31P MRS? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Concussion, Mild
- What is being tested?
- Nicotinamide Riboside
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2016to Aug 2022
- Phase
- Interventional
- 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
- Adult current and former (within 2 years) collegiate athletes (football, rugby, soccer, hockey, and volleyball)
- Body mass index (estimated based on height and weight) from 23 to 37
- Willing to provide informed consent, ingest test substance, and provide blood specimens
- Willing to comply with study instructions and maintain current level of physical activity throughout the study
Who cannot join
- History of loss of consciousness of more than 5 minutes
- Contraindications to Magnetic Resonance Imaging (MRI), such as implanted medical devices, metal objects, or pacemakers
- History of epilepsy
- History of more than 3 concussions
- History of headache preceding a concussion
- History of depression preceding a concussion
Show all 9Show fewer
- History of developmental delays or Attention Deficit Hyperactivity Disorder (ADHD)
- History of post-traumatic seizures
- History of complex spine and/or skull trauma
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota Center for Magnetic Resonance Research
Minneapolis, Minnesota, 55455
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Use of 31P MRS to Assess Brain NAD+ in Healthy Current and Former Collegiate Athletes and a Comparison of the Effect of Nicotinamide Riboside Supplementation on Brain NAD+ Levels
Can nicotinamide riboside (750 mg/day for 12 weeks) affect the levels of NAD+ in the brain as measured by 31P MRS?
Read the detailed description
Healthy collegiate athletes (football, soccer, rugby, hockey, and volleyball) will take Nicotinamide Riboside (NR) or placebo twice daily for 84 days. Pre- and post-intervention evaluations include physical assessment, blood tests for safety and toxicity monitoring, blood tests for biomarkers, neurologic testing, quality of life questionnaires, and the 31P MRI exam.
- Conditions
- Concussion, Mild
- Being tested
- Nicotinamide Riboside, Matching placebo
- Keywords
- Brain Nicotinamide Adenine Dinucleotide (NAD+), Adenosine Triphosphate (ATP) Depletion, Polyadenosine Diphosphate-Ribosepolymerase (PARP) Activation
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide RibosideDietary supplement
Also called Niagen
Three capsules, twice per day for 84 days
Matching placeboOther
Three matching capsules, twice per day for 84 days
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Healthy Collegiate Athletes | Active comparator | Healthy collegiate athletes will take active Nicotinamide Riboside Receives: Dietary Supplement: Nicotinamide Riboside |
| Arm B: Healthy Collegiate Athletes | Placebo comparator | Healthy collegiate athletes will take a matching placebo Receives: Other: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain NAD+ levels
As measured by 31P MRI
Measured: baseline, day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2022
- Study completionAug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, Thorne HealthTech, Inc
- Responsible party
- Principal investigator, Brent A. Bauer, Mayo Clinic
- Investigators
- Brent A Bauer, MD, Principal investigator, Mayo Clinic in Rochester, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721537
- Sponsor's protocol ID
- 15-006870
- Acronym
- TRMC-004
- Status last verified
- Aug 2022
- First submitted
- 24 Mar 2016
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 31P MRS to Assess Brain NAD+ in Healthy Current and Former Collegiate Athletes and a Comparison of the Effect of Nicotinamide Riboside Supplementation on Brain NAD+ Levels
- ClinicalTrials.gov ID
- NCT02721537
- Acronym / sponsor ID
- TRMC-004 / 15-006870
- Conditions
- Concussion, Mild
- Keywords
- Brain Nicotinamide Adenine Dinucleotide (NAD+), Adenosine Triphosphate (ATP) Depletion, Polyadenosine Diphosphate-Ribosepolymerase (PARP) Activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- University of Minnesota, Thorne HealthTech, Inc
- Study start
- Sep 2016
- Primary completion
- Aug 2022 (actual)
- Study completion
- Aug 2022 (actual)
- First posted
- 29 Mar 2016 (estimated)
- 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.
Can nicotinamide riboside (750 mg/day for 12 weeks) affect the levels of NAD+ in the brain as measured by 31P MRS?
Detailed description
Healthy collegiate athletes (football, soccer, rugby, hockey, and volleyball) will take Nicotinamide Riboside (NR) or placebo twice daily for 84 days. Pre- and post-intervention evaluations include physical assessment, blood tests for safety and toxicity monitoring, blood tests for biomarkers, neurologic testing, quality of life questionnaires, and the 31P MRI exam.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Healthy Collegiate Athletes | Active comparator | Dietary Supplement: Nicotinamide RibosideHealthy collegiate athletes will take active Nicotinamide Riboside |
| Arm B: Healthy Collegiate Athletes | Placebo comparator | Other: Matching placeboHealthy collegiate athletes will take a matching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult current and former (within 2 years) collegiate athletes (football, rugby, soccer, hockey, and volleyball)
- Body mass index (estimated based on height and weight) from 23 to 37
- Willing to provide informed consent, ingest test substance, and provide blood specimens
- Willing to comply with study instructions and maintain current level of physical activity throughout the study
Key exclusion criteria (9 listed)
- History of loss of consciousness of more than 5 minutes
- Contraindications to Magnetic Resonance Imaging (MRI), such as implanted medical devices, metal objects, or pacemakers
- History of epilepsy
- History of more than 3 concussions
- History of headache preceding a concussion
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 |
|---|---|---|
| Nicotinamide RibosideAlso: NiagenThree capsules, twice per day for 84 days | Dietary supplement | Arm A: Healthy Collegiate Athletes |
| Matching placeboThree matching capsules, twice per day for 84 days | Other | Arm B: Healthy Collegiate Athletes |
Primary outcome
Change in brain NAD+ levels
Time frame: baseline, day 84
As measured by 31P MRI
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 Aug 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Brent A Bauer, MD principal investigator
Mayo Clinic in Rochester, MN
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotinamide Riboside in people with Concussion, Mild, run by Mayo Clinic at 2 sites 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 4 inclusion and 9 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 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Change in brain NAD+ levels (time frame: baseline, day 84). 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 Aug 2022.