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Plain-language guide to NCT02921659: phase 1, phase 2 randomized trial of NAD+, 30 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02921659
- Phase
- phase 1, phase 2
- Status
- completed
- Start
- 2015-04
- Completion (planned or actual)
- 2016-10
- Participants
- 30 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Aging
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1, phase 2) is built around NAD+.
It had two arms (groups): Placebo (placebo comparator) and Niagen™ (active comparator).
The registry classes the interventions as dietary supplement.
Who Took Part
The registry lists 30 actual participants took part.
It was open to people of any sex aged from 55 years up to 79 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Ability to provide informed consent. Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 2 min, climb 10 stairs). Women will be confirmed as postmenopausal (either natural or surgical) based on cessation of menses for \>1 year.
The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: ages \<55 years or ≥80 years; having past or present alcohol dependence or abuse, as defined by the american psychiatry association, diagnostic and statistical manual of mental disorders; abnormal blood chemistries for renal and liver function (\>1 standard deviation outside the normal range).
How the Study Was Run
The set-up was randomized, crossover and double-blind.
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.
Blinding on both sides kept the participants and researchers unaware of who received NAD+.
Those kept unaware of assignments: participant and investigator.
It started in 2015-04 with completion listed for 2016-10.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Incidence of treatment emergent adverse events (time frame: 6 weeks).
It also tracked 5 secondary outcomes, for example Endothelium Dependent Dilation, Arterial Stiffness, Cognitive Function, Motor Function and Systemic markers of oxidative stress and inflammation.
What This Means in Plain Language
Put simply, this is a phase 1, phase 2, randomized trial of NAD+ in 30 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.