Effect of Inorganic Nitrate Supplement on Blood Pressure
Completed · Not applicable · Has a placebo group
Conditions studied: Blood Pressure, Endothelial Dysfunction
In brief
The primary purpose of this project is to assess the efficacy (effectiveness) of plant-based nitrate tablets to elevate nitric oxide in your system as measured by saliva and effect on lowering blood pressure (BP), supporting blood vessel function in men and women with hypertension.
Key facts
- Study ID
- NCT03909789
- Run by
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- People needed
- 67
- Starts
- 2017-11-17
- Expected to finish
- 2018-06-22
- Last updated by the study team
- 2019-04-12
Who can join
Age: 40 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- age 40-75 years
- Hypertension >130/85 mmHg; men and women, 1:1 and stable medicated hypertensives
- Subjects must provide written informed consent after the scope and nature of the investigation has been explained to them
You may not qualify if…
- Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
- Weight in excess of 250 pounds
- Bleeding disorder
- History of known coronary artery disease, myocardial infarction, stroke or life-threatening arrhythmia within the prior six months
- NYHA Class II- IV heart failure
- History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy
- Serum creatinine > 1.4 mg/dl
- Triglycerides > 400 at visit 1
- Drug or alcohol abuse, or current intake of more than 14 standard drinks per week
- Concurrent enrollment in another placebo-controlled trial
- Partial ileal bypass or known gastrointestinal disease limiting drug absorption
- Current tobacco use
- Current use of anticoagulants (except for anti-platelet agents)
- Renal failure
- History of hypertensive encephalopathy or cerebrovascular accident
- Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI
- Pregnancy
Where it is running
- Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center — Torrance, California, United States
Full record on ClinicalTrials.gov
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