HypertensionPhase 4NCT04903210
Nicotinamide Mononucleotide in Hypertensive Patients
A Phase 4 study testing Nicotinamide mononucleotide supplied as 400mg capsule and Lifestyle modification in people with Hypertension, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Nicotinamide mononucleotide supplied as 400mg capsule and Lifestyle modification
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 31 Jul 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild essential hypertensive patients (BP ranged from 130/80 to 159/99 mmHg).
- Ability to undergo Study procedures.
- Willingness/ability to provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital,Sun Yat-sen University
Guangzhou, Guangdong, 510000
Jun Tao, MD,PhD, +8613922191609, taojungz123@163.com
Yumin Qiu, +8618022232920, qiuym8@mail2.sysu.edu.cn
About this study
Official title: 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.
- Conditions
- Hypertension
- Being tested
- Nicotinamide mononucleotide supplied as 400mg capsule, Lifestyle modification
- Keywords
- Hypertension, β-nicotinamide mononucleotide, Vascular function, Blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide mononucleotide supplied as 400mg capsuleDietary supplement
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 modificationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| NMN group | Experimental | NMN10000 WRIGHT LIFE® + lifestyle modification. Receives: Dietary Supplement: Nicotinamide mononucleotide supplied as 400mg capsule; Behavioral: Lifestyle modification |
| Control group | Other | Lifestyle modification only. Receives: Behavioral: Lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of NMN on flow mediated dilation (FMD)
Change of FMD between NMN-treated participants and non-NMN-treated participants
Measured: 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
Measured: Up to 2 month
Secondary outcomes (4)
Effect of NMN on blood pressure
Change of systolic blood pressure and diastolic blood pressure between NMN-treated participants and non-NMN-treated participants
Measured: 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
Measured: 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.
Measured: Up to 2 month
Incidence of Treatment Adverse Events
Adverse Events
Measured: Up to 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start1 Jun 2021
- Primary completion20 Jun 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Tao, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903210
- Sponsor's protocol ID
- NMNHTN-001
- Status last verified
- May 2021
- First submitted
- 21 May 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Nicotinamide Mononucleotide Supplementation in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT04903210
- Acronym / sponsor ID
- NMNHTN-001
- Conditions
- Hypertension
- Keywords
- Hypertension, β-nicotinamide mononucleotide, Vascular function, Blood pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 20 Jun 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMN group | Experimental | Dietary Supplement: Nicotinamide mononucleotide supplied as 400mg capsule, Behavioral: Lifestyle modificationNMN10000 WRIGHT LIFE® + lifestyle modification. |
| Control group | Other | Behavioral: Lifestyle modificationLifestyle modification only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild essential hypertensive patients (BP ranged from 130/80 to 159/99 mmHg).
- Ability to undergo Study procedures.
- Willingness/ability to provide informed consent.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotinamide mononucleotide supplied as 400mg capsuleNMN10000 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. | Dietary supplement | NMN group |
| Lifestyle modificationLifestyle 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. | Behavioural | Control group, NMN group |
Primary outcome
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
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
4 secondary outcomes
Effect of NMN on blood pressure
Time frame: Up to 2 month
Effect of NMN on PBMC NAD+ levels
Time frame: Up to 2 month
Effect of NMN on sleep quality
Time frame: Up to 2 month
Incidence of Treatment Adverse Events
Time frame: Up to 2 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotinamide mononucleotide supplied as 400mg capsule and Lifestyle modification in people with Hypertension, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Tao (+86 13922191609, taojungz123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of NMN on flow mediated dilation (FMD) (time frame: Up to 2 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.