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History of Changes for Study: NCT02721537
Assessment of Brain NAD+ in College Football Players Taking Nicotinamide Riboside vs Controls (TRMC-004)
Latest version (submitted August 2, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 24, 2016 None (earliest Version on record)
2 July 27, 2016 Study Status, Study Identification, Arms and Interventions and Study Description
3 September 27, 2016 Recruitment Status, Study Status and Contacts/Locations
4 March 23, 2017 Arms and Interventions, Study Status, Eligibility and Study Design
5 July 14, 2017 Study Status
6 September 22, 2017 Contacts/Locations, Arms and Interventions, Eligibility, Study Status, Study Identification, Outcome Measures, Study Design and Study Description
7 February 21, 2018 Study Status
8 January 4, 2019 Contacts/Locations, Study Status, Eligibility and Study Identification
9 January 28, 2019 Contacts/Locations and Study Status
10 January 29, 2019 Contacts/Locations, Study Status and Study Identification
11 January 30, 2020 Study Status and References
12 February 16, 2021 Study Status and Contacts/Locations
13 February 17, 2022 Study Status
14 May 12, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
15 August 2, 2022 Recruitment Status and Study Status
Comparison Format:

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Study NCT02721537
Submitted Date:  March 24, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: 15-006870
Brief Title: Assessment of Brain NAD+ in College Football Players Taking Nicotinamide Riboside vs Controls (TRMC-004)
Official Title: Use of 31P Magnetic Resonance Spectroscopy (MRS) to Assess Brain Nicotinamide Adenine Dinucleotide (NAD+) in College Football Players and a Comparison of the Effect of Nicotinamide Riboside Supplementation on Brain NAD+ Levels vs Controls
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2016
Overall Status: Not yet recruiting
Study Start: May 2016
Primary Completion: March 2017 [Anticipated]
Study Completion: September 2017 [Anticipated]
First Submitted: March 24, 2016
First Submitted that
Met QC Criteria:
March 24, 2016
First Posted: March 29, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 24, 2016
Last Update Posted: March 29, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Mayo Clinic
Responsible Party: Principal Investigator
Investigator: Brent A. Bauer
Official Title: M.D., Professor of Medicine
Affiliation: Mayo Clinic
Collaborators: University of Minnesota
Thorne Research Inc.
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module 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 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. Healthy controls, age-matched athletes who participate in non-contact sports, will also be enrolled and will undergo the same pre-intervention evaluation, at which time their participation will be complete.
Open or close this module Conditions
Conditions: Concussion, Mild
Keywords: Brain Nicotinamide Adenine Dinucleotide (NAD+)
Adenosine Triphosphate (ATP) Depletion
Polyadenosine Diphosphate-Ribosepolymerase (PARP) Activation
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 48 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
No Intervention: Healthy Controls
Healthy collegiate athletes who do not participant in contact sports.
Active Comparator: Arm A: Healthy Football Linemen
Healthy collegiate football linemen will take active Nicotinamide Riboside
Dietary Supplement: Nicotinamide Riboside
Three capsules, twice per day for 84 days
Other Names:
  • Niagen
Placebo Comparator: Arm B: Healthy Football Linemen
Healthy collegiate football linemen will take a matching placebo
Matching placebo
Three matching capsules, twice per day for 84 days
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change in brain NAD+ levels
[ Time Frame: baseline, day 84 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Male
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria for Arms A and B:

  • Adult male collegiate football linemen
  • History of at least 3 years' playing experience at the collegiate level
  • Body mass index (estimated based on height and weight) from 23 to 27
  • 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 for Arms A and B:

  • 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

Inclusion Criteria for Healthy Control Arm:

  • Adult male athletes participating in non-contact sports, i.e. not participating in football, hockey, soccer, boxing, or wrestling, ages 18 and older.
  • Willing and able to provide written informed consent.

Exclusion Criteria for Healthy Control Arm:

  • Contraindications to Magnetic Resonance Imaging (MRI), such as implanted medical devices, metal implants, or pacemakers.
  • Willing and able to provide written informed consent.
Open or close this module Contacts/Locations
Central Contact Person: Karrie M. Fursa
Telephone: 507-266-2218
Email: fursa.karrie@mayo.edu
Central Contact Backup: Sharon F. Kaufman, M.S.
Telephone: 507-283-1605
Email: kaufman.sharon@mayo.edu
Study Officials: Brent A. Bauer, M.D.
Principal Investigator
Mayo Clinic in Rochester, MN
Locations: United States, Minnesota
University of Minnesota Center for Magnetic Resonance Research
Minneapolis, Minnesota, United States, 55455
Contact:Contact: Stacy Valenzuela, RAC 612-624-9926 majes014@umn.edu
Contact:Principal Investigator: Xiao-Hong Zhu, Ph.D.
Mayo Clinic
Rochester, Minnesota, United States, 55905
Contact:Contact: Karrie M. Fursa 507-266-2218 fursa.karrie@mayo.edu
Contact:Contact: Chuck Barta 507-266-5566 barta.charles@mayo.edu
Contact:Principal Investigator: Brent A Bauer, MD
Open or close this module IPDSharing
Plan to Share IPD: Yes
Supporting Information:
Time Frame:
Access Criteria:
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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