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Nicotinamide Mononucleotide in Hypertensive Patients

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Nicotinamide mononucleotide supplied as 400mg capsule
Lifestyle modification
Sponsored by
First Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, β-nicotinamide mononucleotide, Vascular function, Blood pressure

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • First Affiliated Hospital,Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

NMN group

Control group

Arm Description

NMN10000 WRIGHT LIFE® + lifestyle modification.

Lifestyle modification only.

Outcomes

Primary Outcome Measures

Effect of NMN on flow mediated dilation (FMD)
Change of FMD between NMN-treated participants and non-NMN-treated participants
Effect of NMN on brachial-ankle pulse wave velocity (baPWV)
Change of baPWV between NMN-treated participants and non-NMN-treated participants

Secondary Outcome Measures

Effect of NMN on blood pressure
Change of systolic blood pressure and diastolic blood pressure between NMN-treated participants and non-NMN-treated participants
Effect of NMN on PBMC NAD+ levels
Change of peripheral blood mononuclear cells NAD+ levels between NMN-treated participants and non-NMN-treated participants
Effect of NMN on sleep quality
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.
Incidence of Treatment Adverse Events
Adverse Events

Full Information

First Posted
May 21, 2021
Last Updated
January 17, 2022
Sponsor
First Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04903210
Brief Title
Nicotinamide Mononucleotide in Hypertensive Patients
Official Title
Pilot Study of Nicotinamide Mononucleotide Supplementation in Patients With Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 20, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, β-nicotinamide mononucleotide, Vascular function, Blood pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Study biostatistician will be blinded to group (NMN vs. controls)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NMN group
Arm Type
Experimental
Arm Description
NMN10000 WRIGHT LIFE® + lifestyle modification.
Arm Title
Control group
Arm Type
Other
Arm Description
Lifestyle modification only.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nicotinamide mononucleotide supplied as 400mg capsule
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle modification
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of NMN on flow mediated dilation (FMD)
Description
Change of FMD between NMN-treated participants and non-NMN-treated participants
Time Frame
Up to 2 month
Title
Effect of NMN on brachial-ankle pulse wave velocity (baPWV)
Description
Change of baPWV between NMN-treated participants and non-NMN-treated participants
Time Frame
Up to 2 month
Secondary Outcome Measure Information:
Title
Effect of NMN on blood pressure
Description
Change of systolic blood pressure and diastolic blood pressure between NMN-treated participants and non-NMN-treated participants
Time Frame
Up to 2 month
Title
Effect of NMN on PBMC NAD+ levels
Description
Change of peripheral blood mononuclear cells NAD+ levels between NMN-treated participants and non-NMN-treated participants
Time Frame
Up to 2 month
Title
Effect of NMN on sleep quality
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.
Time Frame
Up to 2 month
Title
Incidence of Treatment Adverse Events
Description
Adverse Events
Time Frame
Up to 2 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Tao
Phone
+86 13922191609
Email
taojungz123@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yumin Qiu
Phone
+86 18022232920
Email
qiuym8@mail2.sysu.edu.cn
Facility Information:
Facility Name
First Affiliated Hospital,Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Tao, MD,PhD
Phone
+8613922191609
Email
taojungz123@163.com
First Name & Middle Initial & Last Name & Degree
Yumin Qiu
Phone
+8618022232920
Email
qiuym8@mail2.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Jun Tao, MD,PhD

12. IPD Sharing Statement

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Nicotinamide Mononucleotide in Hypertensive Patients

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