Effect of Inorganic Nitrate Supplement on Blood Pressure

• ClinicalTrials.gov Identifier: NCT03909789
• Recruitment Status: Completed
• First Posted: April 10, 2019
• Last Update Posted: April 12, 2019
• Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Information provided by (Responsible Party): Matthew J. Budoff, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Blood Pressure; Endothelial Dysfunction	Dietary Supplement: Plant based bioequivalent Nitrate supplementation; Dietary Supplement: Placebo	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 67 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double Blind Placebo Controlled
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: 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
• Actual Study Start Date: November 17, 2017
• Actual Primary Completion Date: June 22, 2018
• Actual Study Completion Date: June 22, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: plant based bioequivalent dietary nitrate supplement; 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 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 Comparator: placebo; The Placebo does not contain any nitric oxide supplement.	Dietary Supplement: Placebo; Placebo

Outcome Measures

Primary Outcome Measures :

1. Rate of change in blood pressure [ Time Frame: 12 weeks ]
   change in blood pressure (in millimeters of mercury) over twelve weeks under effect of active treatment and placebo

Secondary Outcome Measures :

1. changes in serum, plasma and salivary Nitrite and Nitrate [ Time Frame: 12 weeks ]
   change in serum nitrate and nitrate levels (in mcg) over 12 weeks comparing active treatment to placebo
2. cardiometabolic relevant biomarkers (as compared to placebo) [ Time Frame: 12 weeks ]
   measures of serum markers of inflammation (Crp) and glucose over 12 weeks in active vs placebo arms

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, California

Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center

Torrance, California, United States, 90502

Sponsors and Collaborators

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cherukuri L, Birudaraju D, Kinninger A, Chaganti BT, Shekar C, Hamal S, Shaikh K, Flores F, Roy SK, Sotka W, Green SJ, Budoff MJ. Effect of a plant-based bioequivalent inorganic nitrate (NO(3)(-)) complex with vitamins, antioxidants and phytophenol rich food extracts in hypertensive individuals - A randomized, double-blind, placebo-controlled study. Clin Nutr ESPEN. 2020 Dec;40:327-335. doi: 10.1016/j.clnesp.2020.08.007. Epub 2020 Sep 7.

• Responsible Party: Matthew J. Budoff, Principal Investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• ClinicalTrials.gov Identifier: NCT03909789
• Other Study ID Numbers: 21835-01
• First Posted: April 10, 2019
• Last Update Posted: April 12, 2019
• Last Verified: April 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Matthew J. Budoff, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center:

Endothelium