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Completed

NCT Number: NCT02721537

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

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

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Key information

Conditions

Concussion, Mild Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota Center for Magnetic Resonance Research, Minneapolis, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nicotinamide riboside

Dietary Supplement

Three capsules, twice per day for 84 days

Other names: Niagen

Matching Placebo

Other

Three matching capsules, twice per day for 84 days

Primary outcomes

  1. Change in brain NAD+ levels

    Time frame: baseline, day 84

    As measured by 31P MRI

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Thorne HealthTech, Inc
  • University of Minnesota

Registry information

Official study 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

Acronym: TRMC-004

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Mar 29, 2016
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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