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Nicotinamide Mononucleotide in Hypertensive Patients

Plain-language guide to NCT04903210: phase 4 randomized trial of NAD+, 20 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT04903210
Phase
phase 4
Status
status unknown
Start
2021-06-01
Completion (planned or actual)
2022-06-20
Participants
20 (estimated)
Design
randomized, single-blind, treatment
Conditions studied
Hypertension
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 4) is built around NAD+.

Cardiovascular and cerebrovascular diseases are most terrible killers endangering the health of Chinese residents, and hypertension is the most important risk factor.

Hypertension related vascular function and structural damage are the common pathological basis and initiation of cardiovascular and cerebrovascular disease.

It had two arms (groups): NMN group (experimental) and Control group (other).

NMN10000 WRIGHT LIFE® + lifestyle modification.

Lifestyle modification only.

The registry classes the interventions as behavioral and dietary supplement.

Who Took Part

20 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Mild essential hypertensive patients (BP ranged from 130/80 to 159/99 mmHg). Ability to undergo Study procedures. Willingness/ability to provide informed consent.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: participants with secondary hypertension; known allergies to niacin or nicotinamide; receiving certain concurrent supplements.

How the Study Was Run

It was run as a randomized, parallel-group and single-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 participants stayed in one arm throughout.

In this single-blind NAD+ study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2021-06-01 with completion listed for 2022-06-20.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Effect of NMN on flow mediated dilation (FMD) (time frame: Up to 2 month). Effect of NMN on brachial-ankle pulse wave velocity (baPWV) (time frame: Up to 2 month).

It also tracked 4 secondary outcomes, for example Effect of NMN on blood pressure, Effect of NMN on PBMC NAD+ levels, Effect of NMN on sleep quality and Incidence of Treatment Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of NAD+ in 20 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; 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.