Nicotinamide Mononucleotide in Hypertensive Patients

Hypertension Clinical Trial

Official title:

Pilot Study of Nicotinamide Mononucleotide Supplementation in Patients With Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04903210
• Other study ID #: NMNHTN-001
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: May 2021
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Jun Tao
• Phone: +86 13922191609
• Email: taojungz123[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 31, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
China	First Affiliated Hospital,Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of NMN on flow mediated dilation (FMD)	Change of FMD between NMN-treated participants and non-NMN-treated participants	Up to 2 month
Primary	Effect of NMN on brachial-ankle pulse wave velocity (baPWV)	Change of baPWV between NMN-treated participants and non-NMN-treated participants	Up to 2 month
Secondary	Effect of NMN on blood pressure	Change of systolic blood pressure and diastolic blood pressure between NMN-treated participants and non-NMN-treated participants	Up to 2 month
Secondary	Effect of NMN on PBMC NAD+ levels	Change of peripheral blood mononuclear cells NAD+ levels between NMN-treated participants and non-NMN-treated participants	Up to 2 month
Secondary	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.	Up to 2 month
Secondary	Incidence of Treatment Adverse Events	Adverse Events	Up to 2 month