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Safety and Pharmacokinetics of Nicotinamide Mononucleotide (NMN) in Healthy Adults.
Plain-language guide to NCT04910061: not phased interventional trial of NAD+, 24 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04910061
- Phase
- not phased
- Status
- completed
- Start
- 2021-08-05
- Completion (planned or actual)
- 2022-09-01
- Participants
- 24 (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
This registered not phased trial tested NAD+.
It had 1 arm (groups): NMN-C (experimental).
Healthy individuals receiving NMN-C.
The registry classes the interventions as dietary supplement.
Who Took Part
Enrollment: 24 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Naturally post-menopausal women with amenorrhea for 1 year will be eligible. BMI between 18.5 and 29.9 kg/m2; with a stable weight over the last 3 months (±2 kg). Having given written informed consent to participate in the research trial.
The full record lists 5 inclusion and 20 exclusion criteria; among the exclusions: known or suspected allergy to any of the ingredients in the investigational product or standardized meals; active infection, or history of infection and/or antibiotic use 2 weeks prior to the screening visit as assessed by investigator; have a history of, or present with, cardiovascular, renal, hepatic, endocrine, gastrointestinal, or inflammatory disease, as assessed by investigator.
How the Study Was Run
Design: single-group and open-label.
Being open-label, the NAD+ study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2021-08-05 with completion listed for 2022-09-01.
It ran at 1 site in Canada.
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: Safety as measured by subject incident of treatment-emergent adverse events (time frame: between Day 1 and Day 30).
It also tracked 17 secondary outcomes, for example Change from baseline in NAD+ and NMN concentrations in whole blood, Change from baseline in NAD+ and NMN concentrations in whole blood, Change from baseline in NAD+ metabolites concentrations in plasma, Change from baseline in NAD+ metabolites concentrations in plasma, Change from baseline in NAD+ metabolites concentrations in urine and Change from baseline in NAD+ metabolites concentrations in urine.
What This Means in Plain Language
Put simply, this is a not phased trial of NAD+ in 24 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.