Clinical trial NCT04903210: Nicotinamide Mononucleotide in Hypertensive Patients
Official title: Pilot Study of Nicotinamide Mononucleotide Supplementation in Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
β-nicotinamide mononucleotide
Vascular function
Blood pressure
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Effect of NMN on flow mediated dilation (FMD)
timeFrame: Up to 2 month
measure: Effect of NMN on brachial-ankle pulse wave velocity (baPWV)
timeFrame: Up to 2 month
Secondary outcomes:
measure: Effect of NMN on blood pressure
timeFrame: Up to 2 month
measure: Effect of NMN on PBMC NAD+ levels
timeFrame: Up to 2 month
measure: Effect of NMN on sleep quality
timeFrame: Up to 2 month
measure: Incidence of Treatment Adverse Events
timeFrame: Up to 2 month
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital,Sun Yat-sen University
state: Guangdong
Study officials:
References: