Use of 31P MRS to Assess Brain NAD+ in Healthy Current and Former Collegiate Athletes

Study Overview
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Brief Summary
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Can nicotinamide riboside (750 mg/day for 12 weeks) affect the levels of NAD+ in the brain as measured by 31P MRS?

Detailed Description
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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.

Official Title
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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

Conditions
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Concussion, Mild

Intervention / Treatment
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* Dietary Supplement: Nicotinamide Riboside
* Other: Matching placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 History of developmental delays or Attention Deficit Hyperactivity Disorder (ADHD) History of post-traumatic seizures History of complex spine and/or skull trauma

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A: Healthy Collegiate Athletes<br>Healthy collegiate athletes will take active Nicotinamide Riboside | Dietary Supplement: Nicotinamide Riboside<br>* Three capsules, twice per day for 84 days<br>* Other names: Niagen;|
| Placebo Comparator: Arm B: Healthy Collegiate Athletes<br>Healthy collegiate athletes will take a matching placebo | Other: Matching placebo<br>* Three matching capsules, twice per day for 84 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in brain NAD+ levels | As measured by 31P MRI | baseline, day 84 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain Nicotinamide Adenine Dinucleotide (NAD+), Adenosine Triphosphate (ATP) Depletion, Polyadenosine Diphosphate-Ribosepolymerase (PARP) Activation