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

Tracking Information
First Submitted Date ICMJE	March 24, 2016
First Posted Date ICMJE	March 29, 2016
Last Update Posted Date	January 8, 2019
Study Start Date ICMJE	September 2016
Estimated Primary Completion Date	December 2019 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 22, 2017)	Change in brain NAD+ levels [ Time Frame: baseline, day 84 ]; As measured by 31P MRI
Original Primary Outcome Measures ICMJE; (submitted: March 24, 2016)	Change in brain NAD+ levels [ Time Frame: baseline, day 84 ]
Change History	Complete list of historical versions of study NCT02721537 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Use of 31P MRS to Assess Brain NAD+ in Healthy Current and Former Collegiate Athletes
Official Title ICMJE	Use of 31P MRS to Assess Brain NAD+ in Healthy Collegiate Athletes and a Comparison of the Effect of Nicotinamide Riboside Supplementation on Brain NAD+ Levels
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 Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Screening
Condition ICMJE	Concussion, Mild
Intervention ICMJE	Dietary Supplement: Nicotinamide Riboside Three capsules, twice per day for 84 days Other Name: Niagen; Other: Matching placebo Three matching capsules, twice per day for 84 days
Study Arms	Active Comparator: Arm A: Healthy Collegiate Athletes Healthy collegiate athletes will take active Nicotinamide Riboside Intervention: Dietary Supplement: Nicotinamide Riboside; Placebo Comparator: Arm B: Healthy Collegiate Athletes Healthy collegiate athletes will take a matching placebo Intervention: Other: Matching placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: March 24, 2016)	48
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	June 2020
Estimated Primary Completion Date	December 2019 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact: Shawn Fokken, CCRP 507-293-2740 fokken.shawn@mayo.edu Contact: Saswati Mahapatra 507-284-5404 mahapatra.saswati@mayo.edu
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT02721537
Other Study ID Numbers ICMJE	15-006870
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: Yes
Responsible Party	Brent A. Bauer, Mayo Clinic
Study Sponsor ICMJE	Mayo Clinic
Collaborators ICMJE	University of Minnesota - Clinical and Translational Science Institute; Thorne Research Inc.
Investigators ICMJE	Principal Investigator: Brent A. Bauer, M.D. Mayo Clinic in Rochester, MN
PRS Account	Mayo Clinic
Verification Date	January 2019
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP