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

Condition Intervention
Concussion, Mild Dietary Supplement: Nicotinamide Riboside Other: Matching placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Screening
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Brent A. Bauer, Mayo Clinic:

Primary Outcome Measures:
  • Change in brain NAD+ levels [ Time Frame: baseline, day 84 ]
    As measured by 31P MRI


Estimated Enrollment: 48
Study Start Date: September 2016
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A: Healthy Collegiate Athletes
Healthy collegiate athletes will take active Nicotinamide Riboside
Dietary Supplement: Nicotinamide Riboside
Three capsules, twice per day for 84 days
Other Name: Niagen
Placebo Comparator: Arm B: Healthy Collegiate Athletes
Healthy collegiate athletes will take a matching placebo
Other: Matching placebo
Three matching capsules, twice per day for 84 days

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721537


Contacts
Contact: Heather Ondler Hinson 507-284-4799 ondlerhinson.heather@mayo.edu
Contact: Karrie M. Fursa 507-266-2218 fursa.karrie@mayo.edu

Locations
United States, Minnesota
University of Minnesota Center for Magnetic Resonance Research Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Stacy Valenzuela, RAC    612-624-9926    majes014@umn.edu   
Principal Investigator: Xiao-Hong Zhu, Ph.D.         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Heather Ondler Hinson    507-284-4799    ondlerhinson.heather@mayo.edu   
Contact: Chuck Barta    507-266-5566    barta.charles@mayo.edu   
Principal Investigator: Brent A Bauer, MD         
Sponsors and Collaborators
Mayo Clinic
University of Minnesota - Clinical and Translational Science Institute
Thorne Research Inc.
Investigators
Principal Investigator: Brent A. Bauer, M.D. Mayo Clinic in Rochester, MN
  More Information

Responsible Party: Brent A. Bauer, M.D., Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02721537     History of Changes
Other Study ID Numbers: 15-006870
First Submitted: March 24, 2016
First Posted: March 29, 2016
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Brent A. Bauer, Mayo Clinic:
Brain Nicotinamide Adenine Dinucleotide (NAD+)
Adenosine Triphosphate (ATP) Depletion
Polyadenosine Diphosphate-Ribosepolymerase (PARP) Activation

Additional relevant MeSH terms:
Niacinamide
Niacin
Nicotinic Acids
Brain Concussion
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents