Status:
RECRUITING
Nicotinamide Riboside for Treating Elevated Systolic Blood Pressure and Arterial Stiffness in Middle-aged and Older Adults
Lead Sponsor:
Douglas Seals
Conditions:
Hypertension
Aging
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief 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 fact...
Detailed Description
Study Overview: This is a randomized, double-blind, placebo-controlled, parallel design, single site phase IIa clinical trial assessing the efficacy of nicotinamide riboside supplementation to lower s...
Eligibility Criteria
Inclusion
- 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
- Absence of other clinical disease as determined by medical history, physical examination, blood chemistries, ankle-brachial index, and 12-lead ECG at rest and during graded treadmill exercise
- Ankle-brachial index \>0.7
- Total cholesterol \<240 mg/dL
- Fasting plasma glucose \<126 mg/dL
- Normal 12-lead ECG at rest and during graded treadmill exercise to fatigue
Exclusion
- Systolic blood pressure \<120 or \>/= 160 mmHg
- Currently taking antihypertensive medications
- Other chronic medical condition (e.g., diabetes, chronic kidney disease, cancer)
- Current smoker
- Alcohol dependence or abuse
- Uncontrolled thyroid disease or change in thyroid medication within previous 3 months
- Abnormal blood pressure response to exercise (drop in SBP below resting pressure or SBP \>160 mmHg or DBP \>115 mmHg)
- Regular vigorous aerobic/endurance exercise (\>4 bouts/weeks, \>30 min/bout at a workload \>6 METS)
Key Trial Info
Start Date :
May 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT03821623
Start Date
May 10 2019
End Date
June 1 2025
Last Update
February 21 2025
Active Locations (1)
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1
Integrative Physiology of Aging Laboratory
Boulder, Colorado, United States, 80309