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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02721537
Other study ID # 15-006870
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date August 2022

Study information

Verified date August 2022
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 2022
Est. primary completion date August 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Nicotinamide Riboside
Three capsules, twice per day for 84 days
Other:
Matching placebo
Three matching capsules, twice per day for 84 days

Locations

Country Name City State
United States University of Minnesota Center for Magnetic Resonance Research Minneapolis Minnesota
United States Mayo Clinic Rochester Minnesota

Sponsors (3)

Lead Sponsor Collaborator
Mayo Clinic Thorne Research Inc., University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in brain NAD+ levels As measured by 31P MRI baseline, day 84
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