Effect of Inorganic Nitrate Supplement on Blood Pressure

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Status: Completed

Conditions: Endothelial Dysfunction; Blood Pressure

Treatments: Dietary Supplement: Plant based bioequivalent Nitrate supplementation; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03909789

21835-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 67 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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67 participants in 2 patient groups, including a placebo group

plant based bioequivalent dietary nitrate supplement

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Plant based bioequivalent Nitrate supplementation

placebo

Placebo Comparator group

Description:

The Placebo does not contain any nitric oxide supplement.

Treatment:

Dietary Supplement: Placebo