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

Concussion, Mild Clinical Trial

— TRMC-004  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02721537
• Other study ID #: 15-006870
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: August 2022

Study information

• Verified date: August 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Mild

Intervention

Dietary Supplement:
• Nicotinamide Riboside
Three capsules, twice per day for 84 days

Other:
• Matching placebo
Three matching capsules, twice per day for 84 days

Locations

Country	Name	City	State
United States	University of Minnesota Center for Magnetic Resonance Research	Minneapolis	Minnesota
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	Thorne Research Inc., University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in brain NAD+ levels	As measured by 31P MRI	baseline, day 84

External Links

•   Mayo Clinic Clinical Trials