Nicotinamide Riboside for Treating Elevated Systolic Blood Pressure and Arterial Stiffness in Middle-aged and Older Adults

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years 3 months later Jun 1, 2025 → Sep 1, 2027
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Record History

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  1. Notable Primary completion pushed from Jun 1, 2025 to Sep 1, 2027 Show 6 more changesShow less
    • Enrollment closed, study ongoing
    • Study completion pushed from Jun 1, 2025 to Oct 1, 2027
    • Eligibility criteria shortened, about 11 words
    • Study description expanded, about 8 words
    • Site details revised
    • Publications: details revised at 3 of 3 entries
  2. Minor Primary and study completion dates: Dec 31, 2024 to Jun 1, 2025v9
  3. Notable Primary and study completion dates: Dec 31, 2023 to Dec 31, 2024v8
  4. Re-verified, no change to tracked fieldsv7
  5. Minor Eligibility criteria revisedv6
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  1. Re-verified, no change to tracked fieldsv5
  2. Minor Primary and study completion dates: Dec 2023 to Dec 31, 2023
    • Start date: Apr 18, 2019 to May 10, 2019
    • Study description expanded, about 1,511 words
    v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 2019 to Apr 18, 2019
    • Site details revised
    v3
  4. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
1,935 trials monitored
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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.
Trial Details
NCT Number NCT03821623
Lead Sponsor Douglas Seals
Conditions
(from sponsor)
Hypertension, Aging
Related terms Hypertension
Enrollment 118 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov