Nicotinamide Mononucleotide in Hypertensive Patients

January 17, 2022 updated by: Jun Tao, First Affiliated Hospital, Sun Yat-Sen University

Pilot Study of Nicotinamide Mononucleotide Supplementation in Patients With Hypertension

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • First Affiliated Hospital,Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Jun Tao, MD,PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: NMN group
NMN10000 WRIGHT LIFE® + lifestyle modification.
Dietary supplement: Nicotinamide mononucleotide supplied as 400mg capsule
NMN10000 WRIGHT LIFE® + lifestyle modification NMN10000 WRIGHT LIFE®: 800mg, qd, for two months. Lifestyle modification: intake 1400-1600 kcal/day: 54% carbohydrates, 24% proteins, 22% lipids, 108 mg cholesterol, 35 g fiber; avoid smoking and alcohol consumption; performing aerobic activity 4 days per week such as 45 min on a stationary bicycle.
Behavioral: Lifestyle modification
Lifestyle modification: intake 1400-1600 kcal/day: 54% carbohydrates, 24% proteins, 22% lipids, 108 mg cholesterol, 35 g fiber; avoid smoking and alcohol consumption; performing aerobic activity 4 days per week such as 45 min on a stationary bicycle.
Other: Control group
Lifestyle modification only.
Behavioral: Lifestyle modification
Lifestyle modification: intake 1400-1600 kcal/day: 54% carbohydrates, 24% proteins, 22% lipids, 108 mg cholesterol, 35 g fiber; avoid smoking and alcohol consumption; performing aerobic activity 4 days per week such as 45 min on a stationary bicycle.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effect of NMN on flow mediated dilation (FMD)
Time Frame: Up to 2 month
Change of FMD between NMN-treated participants and non-NMN-treated participants
Up to 2 month
Effect of NMN on brachial-ankle pulse wave velocity (baPWV)
Time Frame: Up to 2 month
Change of baPWV between NMN-treated participants and non-NMN-treated participants
Up to 2 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effect of NMN on blood pressure
Time Frame: Up to 2 month
Change of systolic blood pressure and diastolic blood pressure between NMN-treated participants and non-NMN-treated participants
Up to 2 month
Effect of NMN on PBMC NAD+ levels
Time Frame: Up to 2 month
Change of peripheral blood mononuclear cells NAD+ levels between NMN-treated participants and non-NMN-treated participants
Up to 2 month
Effect of NMN on sleep quality
Time Frame: Up to 2 month
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.
Up to 2 month
Incidence of Treatment Adverse Events
Time Frame: Up to 2 month
Adverse Events
Up to 2 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NMNHTN-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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