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Nicotinamide Riboside and Mitochondrial Biogenesis
Plain-language guide to NCT03432871: not phased interventional trial of NAD+, 13 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03432871
- Phase
- not phased
- Status
- completed
- Start
- 2017-12-08
- Completion (planned or actual)
- 2022-12-31
- Participants
- 13 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Mitochondrial Diseases; Mitochondrial Myopathies; Progressive External Ophthalmoplegia; Progressive Ophthalmoplegia; Progressive; Ophthalmoplegia, External; Mitochondria DNA Deletion
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested NAD+.
Mitochondria are important parts of the cell that are responsible for producing energy.
It had 1 arm (groups): Nicotinamide Riboside (experimental).
The registry classes the interventions as dietary supplement.
More on the Plan
Mitochondria are the primary source of energy within the cell, in the form of adenosine triphosphate (ATP).
However, before embarking on therapeutic studies, it is essential to develop their understanding of the homeostatic mechanisms.
The aim of this study, therefore, is to investigate the homeostatic mechanisms in this group of individuals because the researchers are most likely to see an effect in this context.
This project consists of two studies, carried out in series.
Who Took Part
The registry lists 13 actual participants took part.
It was open to people of any sex aged from 18 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age 18-70 years. Signed informed patient consent.
The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: females who are at risk of pregnancy (i.e., not using regular contraception), who are pregnant, lactating or planning pregnancy.
How the Study Was Run
It was run as a single-group and open-label study.
Nothing was hidden in this open-label NAD+ study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2017-12-08 with completion listed for 2022-12-31.
It ran at 1 site in United Kingdom.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Bioavailability. Safety - Incidence of treatment related adverse events (time frame: 24 hours). Safety - change in blood analytes (time frame: 24 hours).
What This Means in Plain Language
Put simply, this is a not phased trial of NAD+ in 13 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.