Use of 31P MRS to Assess Brain NAD+ in Healthy Current and Former Collegiate Athletes (TRMC-004)

Mayo Clinic

Status: Completed

Conditions: Concussion, Mild

Treatments: Other: Matching placebo; Dietary Supplement: Nicotinamide Riboside

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02721537

15-006870

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Arm A: Healthy Collegiate Athletes

Active Comparator group

Description:

Healthy collegiate athletes will take active Nicotinamide Riboside

Treatment:

Dietary Supplement: Nicotinamide Riboside

Arm B: Healthy Collegiate Athletes

Placebo Comparator group

Description:

Healthy collegiate athletes will take a matching placebo

Treatment:

Other: Matching placebo