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Nicotinamide Riboside for Treating Elevated Systolic Blood Pressure and Arterial Stiffness in Middle-aged and Older Adults
Plain-language guide to NCT03821623: phase 2 randomized trial of NAD+, low blood pressure and orthostatic hypotension, 118 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03821623
- Phase
- phase 2
- Status
- active, not recruiting
- Start
- 2019-05-10
- Completion (planned or actual)
- 2027-09-01
- Participants
- 118 (estimated)
- Design
- randomized, triple-blind, treatment
- Conditions studied
- Hypertension; Aging
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested NAD+ for low blood pressure and orthostatic hypotension.
It had two arms (groups): Nicotinamide riboside (experimental) and Placebo (placebo comparator).
Subjects will take placebo pills twice a day for 3 months.
The registry classes the interventions as drug and other.
More on the Plan
Nicotinamide riboside is an endogenously occurring precursor of NAD+ and a novel caloric restriction mimetic in humans that is now commercially available as a dietary ingredient/supplement.
As secondary aims, the researchers will also assess safety and tolerability of long-term nicotinamide riboside supplementation, and the effects of nicotinamide riboside supplementation vs. placebo on NAD+ metabolites and circulating biomarkers of vasoconstriction, oxidative stress and inflammation.
Subject Enrollment and Screening: Potential participants will be made aware of the proposed study through described recruitment efforts (see Recruitment and Retention section).
Interested participants will contact a staff research assistant via phone or email (contact information supplied with recruitment materials) and will complete a general screening form online through the Research Electronic Data Capture (REDCap) system to determine eligibility.
Who Took Part
Enrollment: 118 planned participants were the target.
It was open to people of any sex aged from 50 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Ability to provide informed consent. Willing to accept random assignment to condition. Systolic blood pressure between 120 and 159 mmHg. Body mass index \<40 kg/m2. Weight stable in the prior 3 months (\<2 kg weight change) and willing to remain weight stable throughout the study.
The full record lists 10 inclusion and 8 exclusion criteria; among the exclusions: systolic blood pressure \<120 or \>/= 160 mmhg; currently taking antihypertensive medications; other chronic medical condition (e.g., diabetes, chronic kidney disease, cancer).
How the Study Was Run
The set-up was randomized, parallel-group and triple-blind.
The low blood pressure and orthostatic hypotension participants were allocated by chance, so the NAD+ group and the comparison group should start out alike.
The NAD+ group and the comparison group ran side by side rather than switching.
Neither the low blood pressure and orthostatic hypotension participants nor the staff measuring them knew who was on NAD+, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, investigator and outcomes assessor.
It started in 2019-05-10 with completion listed for 2027-09-01.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Systolic blood pressure (time frame: 3 months).
It also tracked 2 secondary outcomes, for example Ambulatory blood pressure and Arterial stiffness.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of NAD+ in 118 people with low blood pressure and orthostatic hypotension.
Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the NAD+ compound page, Low blood pressure and orthostatic hypotension research.
Our Notes on the Compound
NAD+: The coenzyme that accepts electrons at complex I.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.