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Nicotinamide Mononucleotide in Hypertensive Patients

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ClinicalTrials.gov Identifier: NCT04903210
Recruitment Status : Recruiting
First Posted : May 26, 2021
Last Update Posted : February 1, 2022
Sponsor:
Information provided by (Responsible Party):
Jun Tao, First Affiliated Hospital, Sun Yat-Sen University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 1, 2021
Estimated Primary Completion Date : June 20, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. Effect of NMN on flow mediated dilation (FMD) [ Time Frame: Up to 2 month ]
    Change of FMD between NMN-treated participants and non-NMN-treated participants

  2. Effect of NMN on brachial-ankle pulse wave velocity (baPWV) [ Time Frame: Up to 2 month ]
    Change of baPWV between NMN-treated participants and non-NMN-treated participants


Secondary Outcome Measures :
  1. Effect of NMN on blood pressure [ Time Frame: Up to 2 month ]
    Change of systolic blood pressure and diastolic blood pressure between NMN-treated participants and non-NMN-treated participants

  2. Effect of NMN on PBMC NAD+ levels [ Time Frame: Up to 2 month ]
    Change of peripheral blood mononuclear cells NAD+ levels between NMN-treated participants and non-NMN-treated participants

  3. Effect of NMN on sleep quality [ Time Frame: 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.

  4. Incidence of Treatment Adverse Events [ Time Frame: Up to 2 month ]
    Adverse Events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04903210


Contacts
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Contact: Jun Tao +86 13922191609 taojungz123@163.com
Contact: Yumin Qiu +86 18022232920 qiuym8@mail2.sysu.edu.cn

Locations
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China, Guangdong
First Affiliated Hospital,Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Jun Tao, MD,PhD    +8613922191609    taojungz123@163.com   
Contact: Yumin Qiu    +8618022232920    qiuym8@mail2.sysu.edu.cn   
Principal Investigator: Jun Tao, MD,PhD         
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
More Information
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Responsible Party: Jun Tao, Prof., First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT04903210    
Other Study ID Numbers: NMNHTN-001
First Posted: May 26, 2021    Key Record Dates
Last Update Posted: February 1, 2022
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jun Tao, First Affiliated Hospital, Sun Yat-Sen University:
Hypertension
β-nicotinamide mononucleotide
Vascular function
Blood pressure
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
 Micronutrients
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents