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Vitamin
Nicotinamide Riboside for High Blood Pressure
Phase 2
Recruiting
Research Sponsored by Douglas Seals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Summary
This trial will help determine if nicotinamide riboside is a safe and effective way to lower blood pressure and reduce the risk of cardiovascular disease.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of Nicotinamide riboside may include digestive issues such as nausea or indigestion since it affects metabolism. However, specific side effects will be monitored during the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Systolic blood pressure
Secondary study objectives
Ambulatory blood pressure
Arterial stiffness
Other study objectives
Adherence to the intervention (percentage of prescribed pills consumed)
Inflammation
NAD+ and related metabolite blood levels
+4 moreTrial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotinamide riboside
2021
Completed Phase 3
~390
Find a Location
Who is running the clinical trial?
Douglas SealsLead Sponsor
2 Previous Clinical Trials
89 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.Your systolic blood pressure is either too low (less than 120) or too high (160 or more).You are currently taking blood pressure medications.You have a long-term health condition like diabetes, chronic kidney disease, or cancer.You are currently smoking cigarettes.Your body mass index is less than 40.You do not have any other health issues, as determined by your medical history, physical examination, blood tests, ankle-brachial index, and heart tests at rest and during exercise.Your total cholesterol level is less than 240 mg/dL.Your top blood pressure number is between 120 and 159.Your ankle-brachial index is greater than 0.7.You regularly do intense aerobic exercise for more than 30 minutes, at least 4 times a week.Your blood sugar level when fasting is below 126 mg/dL.Your heart's electrical activity is normal at rest and during exercise on a treadmill until you get tired.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Nicotinamide riboside
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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