Effect of Inorganic Nitrate Supplement on Blood Pressure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-17

Study Completion Date

2018-06-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of NO Precursors on Physiological Responses to Exercise

NCT02850367

Physiology

COMPLETED NA

Dietary Nitrate on Blood Pressure and Cardiovascular Disease Risk Factors

NCT03478631

Hypertension Blood Pressure, High

UNKNOWN PHASE3

Study of the Effects of an Oral Nitric Oxide Supplement on Blood Pressure in Prehypertensive Adults

NCT01937754

Prehypertension

UNKNOWN PHASE1/PHASE2

Inter-individual Variation in the Blood Pressure Lowering Effects of Dietary Nitrate

NCT05514821

Blood Pressure

COMPLETED NA

The Acute Effect of Beetroot Juice in Normal and Hypertensive Subjects

NCT01236872

Hypertension

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Pressure Endothelial Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double Blind Placebo Controlled

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Plant based bioequivalent Nitrate supplementation

Intervention Type DIETARY_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.

placebo

The Placebo does not contain any nitric oxide supplement.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes