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To Evaluate the Efficacy and Safety of NMN as an Anti-ageing Supplement in Middle Aged and Older (40-65 Years) Adults

Plain-language guide to NCT04823260: not phased randomized trial of NAD+, anti-aging & longevity, 90 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04823260
Phase
not phased
Status
completed
Start
2021-05-25
Completion (planned or actual)
2021-09-09
Participants
90 (actual)
Design
randomized, quadruple-blind, other
Conditions studied
Aging
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around NAD+ for anti-aging & longevity.

It will be a two-part study.

It had six arms (groups): one (active comparator), one (placebo comparator), one (active comparator), one (placebo comparator) and one (active comparator).

The registry classes the interventions as drug and other.

More on the Plan

During Visit 1 (Screening), informed consent will be obtained before any study procedures take place.

After subject has consented, medical history will then be documented, including the concomitant medications (if any).

Physical examination and ECG will be carried out for all subjects.

Subjects' vital signs will be recorded along with pulse pressure (PP).

Who Took Part

The registry lists 90 actual participants took part.

It was open to people of any sex aged from 40 years up to 65 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Male/females of 40 to 65 years of age. Body Mass Index (BMI) between 18.5 and 35 kg/m2. Able to provide written Informed Consent. Able to follow verbal and written study directions. Must not be taking or be willing to take any supplements containing any form of niacin for seven days prior to baseline and for the duration of the study.

The full record lists 8 inclusion and 16 exclusion criteria; among the exclusions: participants on current use of prescription or over-the-counter nicotinic acid; use of statin drugs; having used any tobacco product or used a recreational drug in the past 6 months.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got NAD+ and who got the comparison, which limits bias.

Groups ran in parallel: each of the anti-aging & longevity participants stayed in one arm throughout.

As a double-blind NAD+ study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-05-25 with completion listed for 2021-09-09.

It ran at 2 sites in India (2).

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Blood cellular NAD+/ NADH (time frame: Baseline). Blood cellular NAD+/ NADH (time frame: 1 month). Blood cellular NAD+/ NADH (time frame: 2 month).

It also tracked 9 secondary outcomes, for example safety of NMN, safety of NMN, Tolerability of NMN, Tolerability of NMN, PART II : Safety of NMN and PART II : Safety of NMN.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of NAD+ in 90 people with anti-aging & longevity.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, Anti-aging & longevity research.

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.