Dietary Nitrate on Blood Pressure and Cardiovascular Disease Risk Factors

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-31

Study Completion Date

2020-08-31

Brief Summary

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The project aims to determine the effect of a high-nitrate dietary intervention on blood pressure and markers of vascular function compared to a low-nitrate intervention in people with elevated blood pressure. Half of the participants will receive the high-nitrate dehydrated vegetable intervention, while the other half will receive the low-nitrate dehydrated vegetable intervention.This project will advance the current hypothesis on the therapeutic link between dietary nitrate and high blood pressure, and potentially derive impactful recommendations for individuals at risk of hypertension.

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Detailed Description

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Diets rich in fruits and in particular, vegetables, reduce blood pressure (BP) and the risk of cardiovascular events. Increasingly, attention is being given to high-nitrate containing vegetables, with emerging evidence that it might represent a source of vasoactive nitric oxide. Clinical data to date uniformly suggest an acute vasoprotective role of dietary nitrate administration and a BP-lowering effect. Whether the vascular effects extend to long-term intake and in individuals with elevated blood pressure is not well known. The investigators hypothesize that consumption of a dietary intervention high in nitrate from vegetable sources will have a greater effect on BP and related vascular parameters than a similar intervention that is low in dietary nitrates.

Conditions

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Hypertension Blood Pressure, High

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will be a randomized, double-blind, controlled parallel study. There will be two experimental arms of 16-week duration, in which participants are assigned to test or control arms under free living conditions in an outpatient setting.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Participants and study coordinators will be blinded to the nature of the treatment allocation. Stratified randomization lists by baseline sex and age will be created.

Study Groups

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High Nitrate Dehydrated Vegetables

Participants are given high-nitrate dehydrated vegetable powders contained in opaque sachets. Participants are advised to consume three sachets per day, over the course of three meals, for 16 weeks.

Group Type EXPERIMENTAL

High-nitrate dehydrated vegetable powder

Intervention Type OTHER

A mixed combination of vegetable powders that are naturally high in nitrate content, such as beet, spinach, and kale

Low-Nitrate Dehydrated Vegetables

Participants are given low-nitrate dehydrated vegetable powders contained in three opaque sachets. Participants are advised to consume three sachets per day, over the course of three meals, for 16 weeks.

Group Type ACTIVE_COMPARATOR

Low-nitrate dehydrated vegetable powder

Intervention Type OTHER

A mixed combination of vegetable powders that are naturally low in nitrate content, such as peas, tomato, broccoli, carrots, and brussel sprouts

Interventions

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High-nitrate dehydrated vegetable powder

A mixed combination of vegetable powders that are naturally high in nitrate content, such as beet, spinach, and kale

Intervention Type OTHER

Low-nitrate dehydrated vegetable powder

A mixed combination of vegetable powders that are naturally low in nitrate content, such as peas, tomato, broccoli, carrots, and brussel sprouts

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* BMI 18.5-35 kg/m2
* Seated systolic blood pressure ≥130 and \<160 mmHg

Exclusion Criteria

* current use of antihypertensive agents
* history of major cardiovascular events in the last 1 year (stroke or myocardial infarction)
* stage II hypertension as per JNC7 criteria (systolic BP/ diastolic BP ≥160/100 mmHg) - angina pectoris
* gastrointestinal (i.e. inflammatory bowel disease, celiac), liver or kidney disease
* cardiac condition that compromises normal function (e.g. mitral valve disease, heart failure)
* serum triglyceride \>4.5mmol/L
* major disability or disorder requiring continuous medical attention
* planned initiation in antihypertensive therapy
* herb or supplement use that may affect primary outcome
* consuming \>3 servings of vegetables/day (based on semi-quantitative food frequency questionnaire)
* alcohol use \>2 drinks/day
* chronic or prescribed use of medications including prescription NSAIDs, antacids, warfarin, medications affecting NO synthesis (ie. sildenafil, organic nitrates, etc)
* use of antibiotics within 3-months of the study start
* participants should also be willing to refrain from using mouthwash (ie chlorhexidine) for the duration of their participation in the study

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No