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NCT03821623 · ClinicalTrials.gov registry record · Phase 2
Nicotinamide Riboside for Treating Elevated Systolic Blood Pressure and Arterial Stiffness in Middle-aged and Older Adults
A Phase 2 study of Hypertension and Aging, sponsored by Douglas Seals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
- 1
- Study location
NCT03821623: Recruiting Phase 2 study of Hypertension and Aging, sponsored by Douglas Seals.
NCT03821623 is a Phase 2 study of Hypertension and Aging that is actively recruiting participants, run by Douglas Seals. The registered enrollment target is 118 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03821623, a Phase 2 study of Hypertension and Aging, is actively recruiting participants, sponsored by Douglas Seals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Resting systolic blood pressure
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Nicotinamide riboside
Study Locations (1)
Colorado
- Integrative Physiology of Aging Laboratory - Boulder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2019-05-10 |
| Est. Completion | 2025-06-01 |
| Phase | Phase 2 |
What NCT03821623 shows while recruiting
NCT03821623 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03821623 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT03821623 about?
NCT03821623 is a clinical study titled "Nicotinamide Riboside for Treating Elevated Systolic Blood Pressure and Arterial Stiffness in Middle-aged and Older Adults". 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 increas...
What is the current status of trial NCT03821623?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2019-05-10. Estimated completion is 2025-06-01.
What conditions does trial NCT03821623 study?
This clinical trial studies the following conditions: Hypertension, Aging.
What interventions are being tested in trial NCT03821623?
The interventions under investigation include: Placebo (OTHER), Nicotinamide riboside (DRUG).
Who is sponsoring clinical trial NCT03821623?
This trial is sponsored by Douglas Seals, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03821623 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03821623's enrollment target sits among peer trials
118 273rd of 470 higher than 196 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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