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The Effects of Nicotinamide Riboside Supplementation on Brain NAD+/NADH Ratio and Bioenergetics

Plain-language guide to NCT03151707: phase 4 interventional trial of NAD+, 11 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03151707
Phase
phase 4
Status
terminated early
Start
2017-10-01
Completion (planned or actual)
2022-09-30
Participants
11 (actual)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Healthy
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested NAD+.

The primary aim of this study is to investigate the effects of exogenously administered nicotinamide riboside (NR) on brain NAD+/NADH ratio and bioenergetics functions in healthy individuals using phosphorus magnetic resonance spectroscopy (31P MRS) imaging.

The secondary aims are to investigate the change in brain PCr/ATP and creatine kinase enzyme rate after NR use.

In addition, NAD+/NADH ratio, PCr/ATP and CK enzyme rate will be measured in the calf muscle, as secondary outcome measures.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 11 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Age: 18-80 year-old. Male or female. Without psychiatric diagnosis according to a structured psychiatric interview (Structured Clinical Interview for DSM-V Axis I Disorders (SCID)). Without history of a psychotic disorder and/or mood disorder among parents, siblings, or children, as obtained via self-report only.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: taking any other medications, including over the counter supplements with the exception of oral contraceptives for women; history of smoking, substance abuse or dependence; difficulty in swallowing capsules.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when NAD+ was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2017-10-01 with completion listed for 2022-09-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline to the End of Treatment in Brain NAD+/NADH Ratio (time frame: Baseline and after 15 days of supplement use).

It also tracked 5 secondary outcomes, for example Change From Baseline to the End of Treatment in Brain Phosphocreatine (PCr) to Adenosine Triphosphate (ATP) Ratio (PCr/ATP), Change From Baseline to the End of Treatment in Brain Creatine Kinase (CK) Enzyme Rate, Change From Baseline to the End of Treatment in Muscle NAD+/NADH Ratio, Change From Baseline to the End of Treatment in Muscle Phosphocreatine (PCr) to Adenosine Triphosphate (ATP) Ratio (PCr/ATP) and Change From Baseline to the End of Treatment in Muscle Creatine Kinase (CK) Enzyme Rate.

What This Means in Plain Language

Put simply, this is a phase 4 trial of NAD+ in 11 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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.