Nicotinamide Mononucleotide in Hypertensive Patients
Pilot Study of Nicotinamide Mononucleotide Supplementation in Patients With Hypertension
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 hypertension
Started Jun 2021
Shorter than P25 for phase_4 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2021
CompletedFirst Posted
Study publicly available on registry
May 26, 2021
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2022
CompletedFebruary 1, 2022
May 1, 2021
1.1 years
May 21, 2021
January 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Effect of NMN on blood pressure
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
Incidence of Treatment Adverse Events
Up to 2 month
Study Arms (2)
NMN group
EXPERIMENTALNMN10000 WRIGHT LIFE® + lifestyle modification.
Control group
OTHERLifestyle modification only.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Mild essential hypertensive patients (BP ranged from 130/80 to 159/99 mmHg).
- Ability to undergo Study procedures.
- Willingness/ability to provide informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Study biostatistician will be blinded to group (NMN vs. controls)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
May 21, 2021
First Posted
May 26, 2021
Study Start
June 1, 2021
Primary Completion
June 20, 2022
Study Completion
July 31, 2022
Last Updated
February 1, 2022
Record last verified: 2021-05