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

NCT ID: NCT02721537

Last Updated: 2022-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2022-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Concussion, Mild

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm A: Healthy Collegiate Athletes

Healthy collegiate athletes will take active Nicotinamide Riboside

Group Type ACTIVE_COMPARATOR

Nicotinamide Riboside

Intervention Type DIETARY_SUPPLEMENT

Three capsules, twice per day for 84 days

Arm B: Healthy Collegiate Athletes

Healthy collegiate athletes will take a matching placebo

Group Type PLACEBO_COMPARATOR

Matching placebo

Intervention Type OTHER

Three matching capsules, twice per day for 84 days

Interventions

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Nicotinamide Riboside

Three capsules, twice per day for 84 days

Intervention Type DIETARY_SUPPLEMENT

Matching placebo

Three matching capsules, twice per day for 84 days

Intervention Type OTHER

Other Intervention Names

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Niagen

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role collaborator

Thorne HealthTech, Inc

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Brent A. Bauer

M.D., Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brent A Bauer, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester, MN

Locations

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University of Minnesota Center for Magnetic Resonance Research

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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15-006870

Identifier Type: -

Identifier Source: org_study_id

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