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

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.
 
ClinicalTrials.gov Identifier: NCT02721537
Recruitment Status : Recruiting
First Posted : March 29, 2016
Last Update Posted : February 5, 2020
Sponsor:
Collaborators:
University of Minnesota
Thorne Research Inc.
Information provided by (Responsible Party):
Brent A. Bauer, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE March 24, 2016
First Posted Date  ICMJE March 29, 2016
Last Update Posted Date February 5, 2020
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date December 31, 2020   (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
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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 Current and Former 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  ICMJE 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  ICMJE
  • 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  ICMJE January 2021
Estimated Primary Completion Date December 31, 2020   (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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Stephanie Lindeen, RN 507-284-4799 athletesstudy@mayo.edu
Contact: Shawn C Fokken, CCRP 507-284-4799 athletesstudy@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  ICMJE
Plan to Share IPD: Yes
Responsible Party Brent A. Bauer, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE
  • University of Minnesota
  • Thorne Research Inc.
Investigators  ICMJE
Principal Investigator: Brent A. Bauer, M.D. Mayo Clinic in Rochester, MN
PRS Account Mayo Clinic
Verification Date January 2020

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