Nicotinamide Mononucleotide in Hypertensive Patients

Pilot Study of Nicotinamide Mononucleotide Supplementation in Patients With Hypertension

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.

Study Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: Dietary supplement: Nicotinamide mononucleotide supplied as 400mg capsule; Behavioral: Lifestyle modification

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jun Tao; Phone Number: +86 13922191609; Email: taojungz123@163.com
• Study Contact Backup: Name: Yumin Qiu; Phone Number: +86 18022232920; Email: qiuym8@mail2.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • First Affiliated Hospital,Sun Yat-sen University
      • Contact: Jun Tao, MD,PhD; Phone Number: +8613922191609; Email: taojungz123@163.com
      • Principal Investigator: Jun Tao, MD,PhD
      • Contact: Yumin Qiu; Phone Number: +8618022232920; Email: qiuym8@mail2.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of NMN on flow mediated dilation (FMD)	Change of FMD between NMN-treated participants and non-NMN-treated participants	Up to 2 month
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Incidence of Treatment Adverse Events	Adverse Events	Up to 2 month

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): June 20, 2022
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 17, 2022
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Hypertension; Blood pressure; Vascular function; β-nicotinamide mononucleotide
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Nicotinic Acids; Niacinamide; Niacin
• Other Study ID Numbers: NMNHTN-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No