Use of 31P MRS to Assess Brain NAD+ in Healthy Current and Former Collegiate Athletes (TRMC-004)
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ClinicalTrials.gov Identifier: NCT02721537 |
Recruitment Status :
Completed
First Posted : March 29, 2016
Last Update Posted : August 3, 2022
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Sponsor:
Mayo Clinic
Collaborators:
University of Minnesota
Thorne Research Inc.
Information provided by (Responsible Party):
Brent A. Bauer, Mayo Clinic
Tracking Information | ||||
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First Submitted Date ICMJE | March 24, 2016 | |||
First Posted Date ICMJE | March 29, 2016 | |||
Last Update Posted Date | August 3, 2022 | |||
Study Start Date ICMJE | September 2016 | |||
Actual Primary Completion Date | August 2022 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Change in brain NAD+ levels [ Time Frame: baseline, day 84 ] As measured by 31P MRI
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Original Primary Outcome Measures ICMJE |
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 |
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Condition ICMJE | Concussion, Mild | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
30 | |||
Original Estimated Enrollment ICMJE |
48 | |||
Actual Study Completion Date ICMJE | August 2022 | |||
Actual Primary Completion Date | August 2022 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
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 |
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Current Responsible Party | Brent A. Bauer, Mayo Clinic | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Mayo Clinic | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Mayo Clinic | |||
Verification Date | August 2022 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |