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Use of 31P MRS to Assess Brain NAD+ in Healthy Collegiate Football Players (TRMC-004)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Mayo Clinic
Sponsor:
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
Thorne Research Inc.
Information provided by (Responsible Party):
Brent A. Bauer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02721537
First received: March 24, 2016
Last updated: September 27, 2016
Last verified: September 2016

March 24, 2016
September 27, 2016
September 2016
March 2017   (final data collection date for primary outcome measure)
Change in brain NAD+ levels [ Time Frame: baseline, day 84 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02721537 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Use of 31P MRS to Assess Brain NAD+ in Healthy Collegiate Football Players
Use of 31P MRS to Assess Brain NAD+ in Healthy Collegiate Football Players and a Comparison of the Effect of Nicotinamide Riboside Supplementation on Brain NAD+ Levels
Can nicotinamide riboside (750 mg/day for 12 weeks) affect the levels of NAD+ in the brain as measured by 31P MRS?
Healthy collegiate football players 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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Concussion, Mild
  • 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
  • Active Comparator: Arm A: Healthy Football Linemen
    Healthy collegiate football linemen will take active Nicotinamide Riboside
    Intervention: Dietary Supplement: Nicotinamide Riboside
  • Placebo Comparator: Arm B: Healthy Football Linemen
    Healthy collegiate football linemen will take a matching placebo
    Intervention: Other: Matching placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
48
September 2017
March 2017   (final data collection date for primary outcome measure)

Inclusion Criteria for Arms A and B:

  • Adult male collegiate football linemen
  • History of at least 3 years' playing experience at the collegiate level
  • Body mass index (estimated based on height and weight) from 23 to 27
  • 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 for Arms A and B:

  • 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

Inclusion Criteria for Healthy Control Arm:

  • Adult male athletes participating in non-contact sports, i.e. not participating in football, hockey, soccer, boxing, or wrestling, ages 18 and older.
  • Willing and able to provide written informed consent.

Exclusion Criteria for Healthy Control Arm:

  • Contraindications to Magnetic Resonance Imaging (MRI), such as implanted medical devices, metal implants, or pacemakers.
  • Willing and able to provide written informed consent.
Male
18 Years and older   (Adult, Senior)
Yes
Contact: Karrie M. Fursa 507-266-2218 fursa.karrie@mayo.edu
Contact: Sharon F. Kaufman, M.S. 507-283-1605 kaufman.sharon@mayo.edu
United States
 
NCT02721537
15-006870
No
Yes
Not Provided
Brent A. Bauer, Mayo Clinic
Mayo Clinic
  • University of Minnesota - Clinical and Translational Science Institute
  • Thorne Research Inc.
Principal Investigator: Brent A. Bauer, M.D. Mayo Clinic in Rochester, MN
Mayo Clinic
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP