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

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02721537

Collaborator

University of Minnesota (Other), Thorne Research Inc. (Industry)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Concussion, Mild	Dietary Supplement: Nicotinamide Riboside Other: Matching placebo	N/A

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

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Screening

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

Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Aug 1, 2022

Actual Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm A: Healthy Collegiate Athletes Healthy collegiate athletes will take active Nicotinamide Riboside	Dietary Supplement: Nicotinamide Riboside Three capsules, twice per day for 84 days Other Names: Niagen
Placebo Comparator: Arm B: Healthy Collegiate Athletes Healthy collegiate athletes will take a matching placebo	Other: Matching placebo Three matching capsules, twice per day for 84 days

Arm

Intervention/Treatment

Active Comparator: Arm A: Healthy Collegiate Athletes

Healthy collegiate athletes will take active Nicotinamide Riboside

Dietary Supplement: Nicotinamide Riboside

Three capsules, twice per day for 84 days

Other Names:

Niagen

Placebo Comparator: Arm B: Healthy Collegiate Athletes

Healthy collegiate athletes will take a matching placebo

Other: Matching placebo

Three matching capsules, twice per day for 84 days

Outcome Measures

Primary Outcome Measures

Change in brain NAD+ levels [baseline, day 84]
As measured by 31P MRI

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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