Study to Evaluate the Effect of Nicotinamide Riboside on Immunity

What Was Tested

In this not phased trial, researchers set out to test NAD+.

Background: The immune system controls how the body responds to infection or injury.

Researchers want to see what effect a dietary supplement called nicotinamide riboside (NR) has on the immune system.

It had two arms (groups): Arm 1 (experimental) and Arm 2 (experimental).

The registry classes the interventions as dietary supplement and drug.

More on the Plan

The cellular programs activated by caloric restriction are similarly turned on in preclinical studies in response to a 24-hour fast.

Interestingly, a recently discovered naturally occurring form of vitamin B3, called nicotinamide riboside (NR), has been found to activate SIRT3.

Putting this together, it would be interesting to evaluate whether the administration of NR to human subjects would replicate the fasting blunting effect on the NLRP3 inflammasome.

Interestingly, at the same time, it has recently been found, in a preclinical study, that the NLRP3 protein can orchestrate differentiation of naive T- cells into Th2 cells.

Who Took Part

38 actual participants took part.

It was open to people of any sex aged from 18 years up to 39 years.

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

Examples of who could join: Males and females between the ages of 18 and 39. BMI between 18.5 and 29.9. Agrees to comply with study procedures and maintain current level of physical activity and dietary intake throughout the study. Female subjects of child-bearing ability willing to commit to reliable contraception while participating in the study.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: subjects with an acute or chronic illness as per history, on laboratory analysis or requiring medications to manage disease; subjects taking vitamins or supplements or any medications, except oral contraceptives, within 4 weeks of participation into this study; BMI \<18.5 or \>29.9.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

Because people in this NAD+ study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Each person switched between NAD+ and the comparison at some point, usually with a gap in between.

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

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2016-06-23 with completion listed for 2018-08-28.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of NAD+ in 38 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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