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

Not Applicable

Completed

• Conditions: Concussion, Mild
• Interventions: Dietary Supplement: Nicotinamide Riboside; Other: Matching placebo

• Registration Number: NCT02721537
• Lead Sponsor: Mayo Clinic

Brief Summary

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 Timeline

• Study First Submitted: 2016-03-24
• Study First Submitted QC: 2016-03-24
• Study First Posted: 2016-03-29
• Study Start: 2016-09
• Status Verified: 2022-08
• Primary Completion: 2022-08
• Study Completion: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Healthy Collegiate Athletes	Nicotinamide Riboside	Healthy collegiate athletes will take active Nicotinamide Riboside
Arm B: Healthy Collegiate Athletes	Matching placebo	Healthy collegiate athletes will take a matching placebo

Primary Outcome Measures

Name	Time	Method
Change in brain NAD+ levels	baseline, day 84	As measured by 31P MRI

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of Minnesota Center for Magnetic Resonance Research; 🇺🇸 Minneapolis, Minnesota, United States