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

Plain-language guide to NCT02721537: not phased randomized trial of NAD+, 30 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02721537
Phase
not phased
Status
completed
Start
2016-09
Completion (planned or actual)
2022-08
Participants
30 (actual)
Design
randomized, double-blind, screening
Conditions studied
Concussion, Mild
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around NAD+.

It had two arms (groups): Arm A: Healthy Collegiate Athletes (active comparator) and Arm B: Healthy Collegiate Athletes (placebo comparator).

Healthy collegiate athletes will take active Nicotinamide Riboside.

Healthy collegiate athletes will take a matching placebo.

The registry classes the interventions as dietary supplement and other.

More on the Plan

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 Took Part

The registry lists 30 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The participants were allocated by chance, so the NAD+ group and the comparison group should start out alike.

The NAD+ group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received NAD+.

Those kept unaware of assignments: participant and investigator.

It started in 2016-09 with completion listed for 2022-08.

It ran at 2 sites in United States (2).

Its stated primary purpose is screening.

What Was Measured

Primary outcome: Change in brain NAD+ levels (time frame: baseline, day 84).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of NAD+ in 30 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, all human trials.

Our Notes on the Compound

NAD+: The coenzyme that accepts electrons at complex I.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.