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

Primary Purpose

Concussion, Mild

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotinamide Riboside
Matching placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Concussion, Mild focused on measuring Brain Nicotinamide Adenine Dinucleotide (NAD+), Adenosine Triphosphate (ATP) Depletion, Polyadenosine Diphosphate-Ribosepolymerase (PARP) Activation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Minnesota Center for Magnetic Resonance Research
  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm A: Healthy Collegiate Athletes

Arm B: Healthy Collegiate Athletes

Arm Description

Healthy collegiate athletes will take active Nicotinamide Riboside

Healthy collegiate athletes will take a matching placebo

Outcomes

Primary Outcome Measures

Change in brain NAD+ levels
As measured by 31P MRI

Secondary Outcome Measures

Full Information

First Posted
March 24, 2016
Last Updated
August 2, 2022
Sponsor
Mayo Clinic
Collaborators
University of Minnesota, Thorne HealthTech, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT02721537
Brief Title
Use of 31P MRS to Assess Brain NAD+ in Healthy Current and Former Collegiate Athletes
Acronym
TRMC-004
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 Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
August 2022 (Actual)
Study Completion Date
August 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
University of Minnesota, Thorne HealthTech, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Mild
Keywords
Brain Nicotinamide Adenine Dinucleotide (NAD+), Adenosine Triphosphate (ATP) Depletion, Polyadenosine Diphosphate-Ribosepolymerase (PARP) Activation

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Healthy Collegiate Athletes
Arm Type
Active Comparator
Arm Description
Healthy collegiate athletes will take active Nicotinamide Riboside
Arm Title
Arm B: Healthy Collegiate Athletes
Arm Type
Placebo Comparator
Arm Description
Healthy collegiate athletes will take a matching placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Nicotinamide Riboside
Other Intervention Name(s)
Niagen
Intervention Description
Three capsules, twice per day for 84 days
Intervention Type
Other
Intervention Name(s)
Matching placebo
Intervention Description
Three matching capsules, twice per day for 84 days
Primary Outcome Measure Information:
Title
Change in brain NAD+ levels
Description
As measured by 31P MRI
Time Frame
baseline, day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brent A Bauer, MD
Organizational Affiliation
Mayo Clinic in Rochester, MN
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Center for Magnetic Resonance Research
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Use of 31P MRS to Assess Brain NAD+ in Healthy Current and Former Collegiate Athletes

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