Nicotinamide Riboside for High Blood Pressure

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Douglas Seals

Must not be taking: Antihypertensives

Disqualifiers: Diabetes, Chronic kidney disease, Cancer, others

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Aging is the primary risk factor for cardiovascular diseases (CVD), the number one cause of death in developed societies. Systolic blood pressure (SBP) increase with age and is a key intermediary factor linking aging to increased CVD risk. The primary mechanisms underlying the age-associated increase in SBP is stiffening of the large elastic arteries, which is mediated by increases in oxidative stress, inflammation, and vascular smooth muscle tone. Regular caloric restriction is effective at lowering SBP in middle-aged and older adults; however, adherence to caloric restriction is poor and may be detrimental to normal weight older adults due to reduced skeletal muscle mass and bone mineral density. Therefore, identification of more practical alternative interventions that mimic the beneficial effects of caloric restriction, with stronger adherence and less risk of adverse consequences, is of significant biomedical importance. Nicotinamide riboside is a naturally occurring precursor of nicotinamide adenine dinucleotide (NAD+), a critical mediator of the beneficial effects of caloric restriction, and therefore a novel caloric restriction mimetic compound. We recently completed the first pilot study of nicotinamide riboside supplementation in healthy middle-aged and older adults and demonstrated that 6 weeks of supplementation decreased systolic blood pressure (SBP) by 8 mmHg in individuals with baseline SBP of 120-139 mmHg (elevated SBP/stage 1 hypertension) compared with placebo, and lowered arterial stiffness, a strong independent predictor of CVD and related morbidity and mortality. As a next translational step, we will conduct a randomized, placebo-controlled, double-blind clinical trial to further assess the safety and efficacy of oral nicotinamide riboside (3 months vs placebo) for decreasing SBP and arterial stiffness in middle-aged and older men and women with SBP between 120 and 139 mmHg at baseline.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking antihypertensive medications.

What data supports the effectiveness of the treatment Nicotinamide Riboside for high blood pressure?

Research suggests that Nicotinamide Riboside, a form of vitamin B3, may help improve cardiovascular health by increasing NAD+ levels in the body, which is important for energy metabolism and cellular function. A study protocol indicates that it is being tested for its potential to decrease systolic blood pressure and arterial stiffness in older adults, which are key factors in managing high blood pressure. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

This trial is for middle-aged and older adults who have slightly elevated blood pressure (120-159 mmHg) and are generally healthy. Participants should not be on blood pressure medication, must have a stable weight, BMI under 40 kg/m2, normal cholesterol and glucose levels, no chronic diseases like diabetes or kidney disease, non-smokers, and not heavy drinkers.

Inclusion Criteria

Ability to provide informed consent

Willing to accept random assignment to condition

Your body mass index is less than 40.

Exclusion Criteria

Your blood pressure doesn't respond normally to exercise, or it goes too high during exercise.

You have a problem with drinking too much alcohol or being dependent on alcohol.

You have a thyroid condition that is not well controlled, or you have changed your thyroid medication in the last 3 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

2 visits (in-person)

Treatment

Participants receive either nicotinamide riboside or placebo for 3 months

12 weeks

6 visits (in-person, bi-weekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Nicotinamide Riboside (Vitamin)
• Placebo (Other)

Trial Overview The study tests if Nicotinamide riboside can lower high systolic blood pressure and make arteries less stiff in people as they age. It's compared to a placebo over three months in a double-blind setup where neither the researchers nor participants know who gets the real supplement.

Participant Groups

Group I: Nicotinamide riboside Experimental Treatment 1 Intervention

Subjects will take 500 mg of the vitamin B3-precursor, nicotinamide riboside (NIAGEN) twice per day (1,000 mg per day total) for 3 months.

Group II: Placebo Placebo Group 1 Intervention

Subjects will take placebo pills twice a day for 3 months.

Who Is Running the Clinical Trial?

Douglas Seals

Lead Sponsor

Trials

3

Recruited

210+

Findings from Research

A 12-week randomized, double-blind, placebo-controlled trial showed that chronic supplementation with nicotinamide riboside (NR), a precursor to NAD+, is well tolerated and effectively increases NAD+ levels in healthy middle-aged and older adults.

The study suggests that NR supplementation may have potential benefits for improving cardiovascular health, specifically in reducing blood pressure and arterial stiffness, warranting further investigation in future clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic nicotinamide riboside supplementation is well-tolerated and elevates NAD+ in healthy middle-aged and older adults. Martens, CR., Denman, BA., Mazzo, MR., et al.[2021]

Nicotinamide riboside (NR) is a promising NAD+ precursor that has shown potential health benefits in treating various conditions, including cardiovascular, neurodegenerative, and metabolic disorders, based on numerous animal and human studies.

Research indicates that NR may also have therapeutic applications against infections, such as SARS-CoV-2, but challenges related to its bioavailability and safety need to be addressed for effective translation into clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotinamide Riboside-The Current State of Research and Therapeutic Uses. Mehmel, M., Jovanović, N., Spitz, U.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety assessment of nicotinamide riboside, a form of vitamin B3. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Chronic nicotinamide riboside supplementation is well-tolerated and elevates NAD+ in healthy middle-aged and older adults. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Safety and Metabolism of Long-term Administration of NIAGEN (Nicotinamide Riboside Chloride) in a Randomized, Double-Blind, Placebo-controlled Clinical Trial of Healthy Overweight Adults. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Nicotinamide Riboside-The Current State of Research and Therapeutic Uses. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Nicotinamide Riboside Supplementation for Treating Elevated Systolic Blood Pressure and Arterial Stiffness in Midlife and Older Adults. [2022]