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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02721537
Recruitment Status : Active, not recruiting
First Posted : March 29, 2016
Last Update Posted : May 16, 2022
Sponsor:
Collaborators:
University of Minnesota
Thorne Research Inc.
Information provided by (Responsible Party):
Brent A. Bauer, Mayo Clinic

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

Condition or disease Intervention/treatment Phase
Concussion, Mild Dietary Supplement: Nicotinamide Riboside Other: Matching placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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 Current and Former Collegiate Athletes and a Comparison of the Effect of Nicotinamide Riboside Supplementation on Brain NAD+ Levels
Study Start Date : September 2016
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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


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

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
Contacts and Locations
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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


Locations
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United States, Minnesota
University of Minnesota Center for Magnetic Resonance Research
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
University of Minnesota
Thorne Research Inc.
Investigators
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Principal Investigator: Brent A Bauer, MD Mayo Clinic in Rochester, MN
More Information
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Additional Information:

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Responsible Party: Brent A. Bauer, M.D., Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02721537    
Other Study ID Numbers: 15-006870
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: May 16, 2022
Last Verified: May 2022
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:
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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
Niacinamide
 Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents