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Trial · Interventional

Status unknownPhase 4Registry data

Nicotinamide Mononucleotide in Hypertensive Patients

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
20 participants (estimated)
Sponsor
First Affiliated Hospital, Sun Yat-Sen University · Other
Design
Randomized · Single masking
Countries
1 country

China

Start
1 Jun 2021
Primary completion
20 Jun 2022 (estimated)
Completion
31 Jul 2022 (estimated)
First posted
26 May 2021
Last update posted
1 Feb 2022
Conditions
Hypertension

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 4

    Nicotinamide Mononucleotide in Hypertensive Patients

    NCT04903210

    1 Jun 2021 to est. 31 Jul 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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. Therefore, reducing blood pressure and delaying or reversing vascular injury is an effective way to treat hypertension and prevent cardiovascular disease. NAD+ (nicotinamide adenine dinucleotide) is a coenzyme of many kinds of dehydrogenases in the body, and is an essential molecule in the basic process of life support. The latest research found that with the growth of age, the level of NAD+ is decreasing, and increasing the content of NAD+ can prolong the life of multiple species including human. NMN (β - nicotinamide mononucleotide) is a natural NAD+ precursor in cells. Recent clinical trials found that NMN supplementation can effectively improve the level of NAD+ in cells, delay aging, improve the metabolic process of cells without adverse reactions. However, the effect of NMN supplementation on reducing blood pressure and protecting vascular endothelial function has not been reported. Therefore, this study aims to focus on hypertension, a major chronic disease, and to observe the effects of NMN supplementation on vascular function and blood pressure in patients with hypertension, so as to provide a new treatment strategy for hypertension and associated vascular injury.

Interventions

  • Nicotinamide mononucleotide supplied as 400mg capsuleDietary supplement
  • Lifestyle modificationBehavioral

Arms2

  • Experimental

    NMN group

    NMN10000 WRIGHT LIFE® + lifestyle modification.

  • Other

    Control group

    Lifestyle modification only.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Effect of NMN on flow mediated dilation (FMD)

    Time frame · Up to 2 month

    Registry description

    Change of FMD between NMN-treated participants and non-NMN-treated participants

  2. Effect of NMN on brachial-ankle pulse wave velocity (baPWV)

    Time frame · Up to 2 month

    Registry description

    Change of baPWV between NMN-treated participants and non-NMN-treated participants

Secondary outcomes(4)
  1. Effect of NMN on blood pressure

    Time frame · Up to 2 month

    Registry description

    Change of systolic blood pressure and diastolic blood pressure between NMN-treated participants and non-NMN-treated participants

  2. Effect of NMN on PBMC NAD+ levels

    Time frame · Up to 2 month

    Registry description

    Change of peripheral blood mononuclear cells NAD+ levels between NMN-treated participants and non-NMN-treated participants

  3. Effect of NMN on sleep quality

    Time frame · Up to 2 month

    Registry description

    Change of the scores of Pittsburgh Sleep Quality Index (PSQI). The final score ranges from 0 to 21. The higher the score, the worse the sleep quality.

  4. Incidence of Treatment Adverse Events

    Time frame · Up to 2 month

    Registry description

    Adverse Events

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Mild essential hypertensive patients (BP ranged from 130/80 to 159/99 mmHg). * Ability to undergo Study procedures. * Willingness/ability to provide informed consent. Exclusion Criteria: * Participants with secondary hypertension. * Participants suffering from diabetes mellitus, coronary heart disease, peripheral vascular disease, acute or chronic liver disease, renal insufficiency, malignancies, infectious disease, or using non-steroidal anti-inflammatory drugs, steriods, vasoactive agents. * Known allergies to niacin or nicotinamide. * Receiving certain concurrent supplements. * Women who are currently pregnant or who wish to become pregnant over the course of the study follow-up or who are at suckling period. * Unwillingness/inability to provide informed consent.

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