Effect of Nicotinamide Riboside on Ketosis, Fat Oxidation & Metabolic Rate

What Was Tested

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

This means that they store too much fat in the liver.

At the moment lifestyle changes are the only way to treat this problem.

It had three arms (groups): Men with overweight or obesity (experimental), MODY2 Patients (experimental) and Women with overweight or obesity (experimental).

To investigate whether NR supplementation augments the sleeping energy expenditure and fat oxidation rate during the ketogenic diet in men and women with overweight and obesity.

To measure changes in sleeping energy expenditure and fat oxidation rate after transitioning from a baseline diet to an isocaloric ketogenic diet similar to their previous study in men.

To investigate whether NR supplementation augments the sleeping energy expenditure and fat oxidation rate during the ketogenic diet in men and women with overweight and obesity.

The registry classes the interventions as dietary supplement and other.

More on the Plan

Exploratory comparison of the above diet-related endpoints between patients with MODY2 and those obtained during the Placebo period in other participants.

Several exploratory measurements are planned to help comprehensively phenotype the effects of the diets and nicotinamide riboside supplementation and are intended to be hypothesis-generating.

Who Took Part

The registry lists 100 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Meet one of the following:. Adult males aged 18-65 years. Pre-menopausal adult females aged 18-50 years. Body mass index (BMI) \>= 25 kg/m\^2 (of \>=18.5 kg/m\^2 for patients with MODY2). Able to cycle at a moderate rate and intensity with a HR equal to or greater than 0.3x(220-age-HRrest)+HRrest but not exceeding 0.4x(220-age-HRrest)+HRrest with no signs of arrhythmia.

The full record lists 8 inclusion and 17 exclusion criteria; among the exclusions: individuals taking prescription medications to treat hypertension in participants without mody2; participating in a regular exercise program (\> 2h/week of vigorous activity) as determined by volunteer report; positive pregnancy test (only for people who can get pregnant).

How the Study Was Run

The set-up was randomized, crossover and double-blind.

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

In the crossover set-up each of the participants took both NAD+ and the comparison in turn, acting as their own control.

As a double-blind NAD+ study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2024-01-08 with completion listed for 2027-01-31.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Primary outcome: Mean change in sleeping energy expenditure between the ketogenic diet and the baseline run-in diet (time frame: 7 days). Mean difference in sleeping energy expenditure between NR and placebo during the ketogenic diet (time frame: 5 days).

It also tracked 2 secondary outcomes, for example Mean change in sleeping fat oxidation rate between the ketogenic diet and the baseline run-in diet and Mean difference in fat oxidation rate between NR and placebo during the ketogenic diet.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of NAD+ in 100 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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