Nicotinamide Mononucleotide in Hypertensive Patients

Sponsor

First Affiliated Hospital, Sun Yat-Sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04903210

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Dietary Supplement: Nicotinamide mononucleotide supplied as 400mg capsule Behavioral: Lifestyle modification	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Study biostatistician will be blinded to group (NMN vs. controls)

Primary Purpose:

Treatment

Official Title:

Pilot Study of Nicotinamide Mononucleotide Supplementation in Patients With Hypertension

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Jun 20, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Effect of NMN on flow mediated dilation (FMD) [Up to 2 month]
Change of FMD between NMN-treated participants and non-NMN-treated participants
Effect of NMN on brachial-ankle pulse wave velocity (baPWV) [Up to 2 month]
Change of baPWV between NMN-treated participants and non-NMN-treated participants

Secondary Outcome Measures

Effect of NMN on blood pressure [Up to 2 month]
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 [Up to 2 month]
Change of peripheral blood mononuclear cells NAD+ levels between NMN-treated participants and non-NMN-treated participants
Effect of NMN on sleep quality [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.
Incidence of Treatment Adverse Events [Up to 2 month]
Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.