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临床试验/NCT04903210
NCT04903210Unknown4 期

Pilot Study of Nicotinamide Mononucleotide Supplementation in Patients With Hypertension

First Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
20
试验地点
1
主要终点
Effect of NMN on brachial-ankle pulse wave velocity (baPWV)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mild essential hypertensive patients (BP ranged from 130/80 to 159/99 mmHg).
  • Ability to undergo Study procedures.
  • Willingness/ability to provide informed consent.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: Up to 2 month

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

Effect of NMN on flow mediated dilation (FMD)

时间窗: Up to 2 month

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

次要结局

  • Effect of NMN on blood pressure(Up to 2 month)
  • Incidence of Treatment Adverse Events(Up to 2 month)
  • Effect of NMN on PBMC NAD+ levels(Up to 2 month)
  • Effect of NMN on sleep quality(Up to 2 month)

研究者

发起方
First Affiliated Hospital, Sun Yat-Sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jun Tao

Prof.

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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