Effect of Inorganic Nitrate Supplement on Blood Pressure

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Acute and Sustained Effects of Plant- Based Bio-Equivalent Nitrate Supplement Tablets on Blood Pressure Reduction, Nitric Oxide Mediated Endothelial Function and Saliva Bioconversion of Dietary Nitrate in Hypertensive Men and Women

Conditions
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Blood Pressure, Endothelial Dysfunction

Intervention / Treatment
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* Dietary Supplement: Plant based bioequivalent Nitrate supplementation
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double Blind Placebo Controlled
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: plant based bioequivalent dietary nitrate supplement<br>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<br>* 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.<br>|
| Placebo Comparator: placebo<br>The Placebo does not contain any nitric oxide supplement. | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of change in blood pressure | change in blood pressure (in millimeters of mercury) over twelve weeks under effect of active treatment and placebo | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endothelium