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Effects of Nicotinamide Riboside on Metabolism and Vascular Function

Plain-language guide to NCT03501433: not phased randomized trial of NAD+, 16 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03501433
Phase
not phased
Status
completed
Start
2018-02-01
Completion (planned or actual)
2019-12-01
Participants
16 (actual)
Design
randomized, double-blind, basic_science
Conditions studied
Aging; Lipemia
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

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

The purpose of this study is to determine the effects of Nicotinamide Riboside (NR) supplementation on metabolism and vascular function following high-fat meal.

Differences between young (18-35) and older (60-75) adults will be determined.

It had two arms (groups): Nicotinamide Riboside Chloride (Niagen) (experimental) and Placebo (placebo comparator).

7 days of placebo supplementation (2/day).

The registry classes the interventions as dietary supplement.

More on the Plan

The purpose of this study is to determine the effects of 7 days of Nicotinamide Riboside (NR) or placebo supplementation on metabolism and vascular function following high-fat meal.

Who Took Part

16 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Age 18 to 35 (young) and 60 to 75 (older). Normo- or pre-hypertensive (blood pressure \<140/90 mmHg). Able to give informed consent and participate in all laboratory visits.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: currently taking any medications that could interfere with cardiovascular or metabolic outcomes will be excluded from the study (e.g., beta-blockers); known metabolic (e.g. type i or type ii diabetes, cardiovascular disease, etc.) or immunologic (e.g. hiv, cancer, autoimmune, etc.) diseases; food allergies to egg, milk, soy or wheat.

How the Study Was Run

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

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.

Neither the participants nor the staff measuring them knew who was on NAD+, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2018-02-01 with completion listed for 2019-12-01.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): NAD+ (time frame: 7 days).

It also tracked 3 secondary outcomes, for example Vasodilatory responsiveness, Lipdemia and Oxidative stress and inflammation.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of NAD+ in 16 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.