118 Participants Needed

Nicotinamide Riboside for High Blood Pressure

DH
Overseen ByDaniel H Craighead, PhD
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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.12345

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.

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.
See 7 more

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.
See 5 more

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
  • Placebo
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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nicotinamide ribosideExperimental Treatment1 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: PlaceboPlacebo Group1 Intervention
Subjects will take placebo pills twice a day for 3 months.

Nicotinamide Riboside is already approved in United States, European Union for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Niagen for:
  • Dietary supplement for general health and wellness
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Niagen for:
  • Dietary supplement for general health and wellness

Find a Clinic Near You

Who Is Running the Clinical Trial?

Douglas Seals

Lead Sponsor

Trials
3
Recruited
210+

Findings from Research

Nicotinamide riboside (NR), a form of vitamin B3, was found to be safe in various toxicity studies, including a 90-day rat study, with no genotoxic effects and no mortality at high doses (5000 mg/kg).
The lowest observed adverse effect level for NR was determined to be 1000 mg/kg/day, indicating that while it is generally safe, higher doses may lead to toxicity in organs such as the liver and kidneys.
Safety assessment of nicotinamide riboside, a form of vitamin B3.Conze, DB., Crespo-Barreto, J., Kruger, CL.[2019]
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.
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]
In an 8-week clinical trial with overweight but healthy participants, nicotinamide riboside (NR) significantly increased whole blood NAD+ levels in a dose-dependent manner, with increases of 22%, 51%, and 142% for doses of 100, 300, and 1000 mg, respectively.
The study found NR to be safe, with no significant adverse effects reported compared to placebo, and it did not negatively impact cholesterol levels or 1-carbon metabolism, supporting its potential as a dietary supplement.
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.Conze, D., Brenner, C., Kruger, CL.[2023]

References

Safety assessment of nicotinamide riboside, a form of vitamin B3. [2019]
Chronic nicotinamide riboside supplementation is well-tolerated and elevates NAD+ in healthy middle-aged and older adults. [2021]
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]
Nicotinamide Riboside-The Current State of Research and Therapeutic Uses. [2021]
Nicotinamide Riboside Supplementation for Treating Elevated Systolic Blood Pressure and Arterial Stiffness in Midlife and Older Adults. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity