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

NCT02721537 | Completed

• 1 other identifier: 15-006870
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Concussion, Mild

Keywords

Brain Nicotinamide Adenine Dinucleotide (NAD+); Adenosine Triphosphate (ATP) Depletion; Polyadenosine Diphosphate-Ribosepolymerase (PARP) Activation

Outcome Measures

Primary Outcomes (1)

• Change in brain NAD+ levels

  As measured by 31P MRI

  baseline, day 84

Study Arms (2)

Arm A: Healthy Collegiate Athletes

ACTIVE COMPARATOR

Healthy collegiate athletes will take active Nicotinamide Riboside

Dietary Supplement: Nicotinamide Riboside

Arm B: Healthy Collegiate Athletes

PLACEBO COMPARATOR

Healthy collegiate athletes will take a matching placebo

Other: Matching placebo

Interventions

Nicotinamide Riboside DIETARY_SUPPLEMENT

Three capsules, twice per day for 84 days

Also known as: Niagen

Arm A: Healthy Collegiate Athletes

Matching placebo OTHER

Three matching capsules, twice per day for 84 days

Arm B: Healthy Collegiate Athletes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• University of Minnesota: collaborator
• Thorne HealthTech, Inc: collaborator

Study Sites (2)

University of Minnesota Center for Magnetic Resonance Research

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Brain Concussion

Interventions

nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

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

Study Officials

• Brent A Bauer, MD

  Mayo Clinic in Rochester, MN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Professor of Medicine

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: March 29, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share

Locations

US (2)