Dietary Nitrate on Blood Pressure and Cardiovascular Disease Risk Factors

Unity Health Toronto90 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hypertension

Interventions

High-nitrate dehydrated vegetable powderOTHER

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

Low-nitrate dehydrated vegetable powderOTHER

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

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Systolic Blood Pressure

Change in systolic blood pressure vs. control at 16 weeks

Time frame: Baseline, 8 and16 weeks

Secondary Outcomes

Mean 24h and Daytime Ambulatory Systolic, Diastolic and Mean Arterial Blood Pressure

Change in mean 24h and daytime ambulatory systolic, diastolic and mean arterial blood pressure vs. control at 16 weeks

Time frame: Baseline and 16 weeks

Aortic Systolic and Diastolic Blood Pressure

Change in aortic systolic and diastolic blood pressure vs. control at 16 weeks

Time frame: Baseline, 8 and 16 weeks

Pulse Wave Velocity (PWV)

Change in PWV vs. control at 16 weeks

Time frame: Baseline and 16 weeks

Augmentation Index (AI)

Change in AI vs. control at 16 weeks

Time frame: Baseline, 8 and 16 weeks

High Sensitivity C-reactive protein (hs-CRP)

Change in hs-CRP vs. control at 16 weeks

Time frame: Baseline and 16 weeks

Plasma Lipids

Change in Total-C, LDL-C, HDL-C vs. control at 16 weeks

Time frame: Baseline and 16 weeks

Dietary Nitrate on Blood Pressure and Cardiovascular Disease Risk Factors

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts