An interventional study of Plant based bioequivalent Nitrate supplementation and Placebo in Blood Pressure and Endothelial Dysfunction, sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. Completed at 1 site in United States. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-12.
Sponsored by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · Not applicable, Interventional, and Prevention
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.
This clinical trial is to assess the efficacy of plant-based bioequivalent Nitric Oxide supplement for improving blood pressure and endothelial reactivity over a 12 weeks intervention period in individuals with metabolic syndrome. The study also examines the effect of plant-based bioequivalent Nitric Oxide supplement on other markers of cardiovascular function and cardiovascular disease risk including Total, LDL and HDL-Cholesterol, Triglycerides, and a multitude of inflammatory markers.
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center is the lead sponsor of 67 studies on the registry; 1 is open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 5 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The nitrate supplement consists of nitrate-rich beetroot extract 20mg, thiamine mononitrate 90mg, potassium nitrate 480mg, ascorbic acid 150mg, folic acid 200mcg, methylcobalamin 200mcg, calcium 115mg, pomegranate fruit extract 5mg and green coffee bean extract 115mg.
Dietary Supplement: Plant based bioequivalent Nitrate supplementation
The Placebo does not contain any nitric oxide supplement.
Dietary Supplement: Placebo
The nitrate supplement consists of nitrate-rich beetroot extract 20mg, thiamine mononitrate 90mg, potassium nitrate 480mg, ascorbic acid 150mg, folic acid 200mcg, methylcobalamin 200mcg, calcium 115mg, pomegranate fruit extract 5mg and green coffee bean extract 115mg.
Placebo
Rate of change in blood pressure
change in blood pressure (in millimeters of mercury) over twelve weeks under effect of active treatment and placebo
Time frame: 12 weeks
changes in serum, plasma and salivary Nitrite and Nitrate
change in serum nitrate and nitrate levels (in mcg) over 12 weeks comparing active treatment to placebo
Time frame: 12 weeks
cardiometabolic relevant biomarkers (as compared to placebo)
measures of serum markers of inflammation (Crp) and glucose over 12 weeks in active vs placebo arms
Time frame: 12 weeks
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center