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

This study is currently recruiting participants.
Verified September 2017 by Brent A. Bauer, Mayo Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT02721537
First Posted: March 29, 2016
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
Thorne Research Inc.
Information provided by (Responsible Party):
Brent A. Bauer, Mayo Clinic
March 24, 2016
March 29, 2016
September 25, 2017
September 2016
December 2017   (Final data collection date for primary outcome measure)
Change in brain NAD+ levels [ Time Frame: baseline, day 84 ]
As measured by 31P MRI
Change in brain NAD+ levels [ Time Frame: baseline, day 84 ]
Complete list of historical versions of study NCT02721537 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Use of 31P MRS to Assess Brain NAD+ in Healthy Collegiate Athletes
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
Can nicotinamide riboside (750 mg/day for 12 weeks) affect the levels of NAD+ in the brain as measured by 31P MRS?
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Screening
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 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
48
June 2018
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact: Heather Ondler Hinson 507-284-4799 ondlerhinson.heather@mayo.edu
Contact: Karrie M. Fursa 507-266-2218 fursa.karrie@mayo.edu
United States
 
 
NCT02721537
15-006870
No
Not Provided
Plan to Share IPD: Yes
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 2017

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