← Human Trials & Peer-Reviewed Studies
Pharmacodynamics and Tolerance of Nicotinamide Mononucleotide (NMN, [amount hidden]) in Healthy Adults
Plain-language guide to NCT04862338: not phased interventional trial of NAD+, 17 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04862338
- Phase
- not phased
- Status
- completed
- Start
- 2021-04-26
- Completion (planned or actual)
- 2021-09-08
- Participants
- 17 (actual)
- Design
- na, open label (everyone knows who gets what), basic_science
- Conditions studied
- Healthy Volunteers
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test NAD+.
It had 1 arm (groups): Nicotinamide mononucleotide (NMN-C) (experimental).
The registry classes the interventions as dietary supplement.
Who Took Part
Enrollment: 17 actual participants took part.
It was open to people of any sex aged from 30 years up to 60 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Men between the ages of 30 and 60 years old. With a BMI between 23 and 30 kg/m2. With a weight \> or = 70kg. Giving their free informed consent to the study.
The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: a history of allergy to vitamin b3 (niacin or nicotinamide); immunocompromised or suffering from a serious or progressive disease (cardiac, pulmonary, hepatic, renal, hematologic, neoplastic or infectious); with abnormal results on the screening bioassay (cbc, transaminases (ast, alt, ggt), bilirubin, creatinine, cpk, ionogram, blood glucose, hba1c, lipid profile).
How the Study Was Run
It was run as a single-group and open-label study.
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 2021-04-26 with completion listed for 2021-09-08.
It ran at 1 site in France.
Its stated primary purpose is basic science.
What Was Measured
Primary outcome: Change from baseline in NAD+ concentrations in whole blood (time frame: Day 0, Day 14 and Day 28).
It also tracked 18 secondary outcomes, for example Change from baseline in NMN concentrations in whole blood, Change from baseline NAD+ metabolite concentrations in plasma, Change from baseline NAD+ metabolite concentrations in urine, Adverse events, Evolution of the mitochondrial DNA ratio and Evolution of blood glucose levels.
What This Means in Plain Language
Put simply, this is a not phased trial of NAD+ in 17 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.