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Nicotinamide Riboside and Mitochondrial Metabolism

Plain-language guide to NCT03951285: not phased non-randomized trial of NAD+, 56 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03951285
Phase
not phased
Status
completed
Start
2016-05-25
Completion (planned or actual)
2019-05-31
Participants
56 (actual)
Design
non-randomized, open label (everyone knows who gets what), prevention
Conditions studied
Obesity
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested NAD+.

Vitamin B3 has recently been found to be a potent modifier of energy metabolism, especially the function of mitochondria.

Mitochondria power up all cells in their bodies, by generating fuel, ATP, for cellular functions.

In previous studies, it has been discovered that mitochondrial biogenesis and oxidative metabolism in adipose tissue is severely impaired in obesity, already at a young adult age.

It had two arms (groups): NR (experimental) and Placebo (placebo comparator).

The registry classes the interventions as dietary supplement.

Who Took Part

56 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: BMI \>18.5 kg/m2 in both members of the twin pair. Agreed to maintain current level of physical activity throughout the study. Agreed to avoid vitamin supplementation or nutritional products with vitamin B3 14 days prior to the enrolment and during the study. Written, informed consent to participate in the study.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: unstable medical conditions as determined by the principal investigator; subjects who have a planned surgery during the course of the trial; history of blood/bleeding disorders.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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.

It started in 2016-05-25 with completion listed for 2019-05-31.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Mitochondrial biogenesis - mitochondrial DNA quantification (time frame: At baseline and 5 months after supplementation). Mitochondrial biogenesis - mitochondria-related mRNA expression (time frame: At baseline and 5 months after supplementation). Mitochondrial biogenesis - electron microscopy (time frame: At baseline and 5 months after supplementation).

It also tracked 2 secondary outcomes, for example NAD+ and related metabolite levels in blood and Skeletal muscle mitochondrial oxidative capacity.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of NAD+ in 56 people.

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.