Use of 31P MRS to Assess Brain NAD+ in Healthy Collegiate Football Players (TRMC-004)

This study is currently recruiting participants.

See

Contacts and Locations

Verified July 2017 by Brent A. Bauer, Mayo Clinic

Sponsor:

Collaborators:

University of Minnesota - Clinical and Translational Science Institute

Thorne Research Inc.

Information provided by (Responsible Party):

Brent A. Bauer, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT02721537

First received: March 24, 2016

Last updated: July 14, 2017

Last verified: July 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

March 24, 2016

Last Updated Date

July 14, 2017

Start Date ^ICMJE

September 2016

Estimated Primary Completion Date

December 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in brain NAD+ levels [ Time Frame: baseline, day 84 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT02721537 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Use of 31P MRS to Assess Brain NAD+ in Healthy Collegiate Football Players

Official Title ^ICMJE

Use of 31P MRS to Assess Brain NAD+ in Healthy Collegiate Football Players 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 football players 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

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Other

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

Active Comparator: Arm A: Healthy Football Players
Healthy collegiate football players will take active Nicotinamide Riboside

Intervention: Dietary Supplement: Nicotinamide Riboside
Placebo Comparator: Arm B: Healthy Football Players
Healthy collegiate football players 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

Estimated Completion Date

June 2018

Estimated Primary Completion Date

December 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adult male collegiate football players
History of at least 1 year playing experience at the collegiate level
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

Sexes Eligible for Study:

Male

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Karrie M. Fursa	507-266-2218	fursa.karrie@mayo.edu
Contact: Sharon F. Kaufman, M.S.	507-283-1605	kaufman.sharon@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

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Plan to Share IPD:

Yes

Responsible Party

Brent A. Bauer, Mayo Clinic

Study Sponsor ^ICMJE

Mayo Clinic

Collaborators ^ICMJE

University of Minnesota - Clinical and Translational Science Institute
Thorne Research Inc.

Investigators ^ICMJE

Principal Investigator:

Brent A. Bauer, M.D.

Mayo Clinic in Rochester, MN

PRS Account

Mayo Clinic

Verification Date

July 2017

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

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