Acute Effect of Nitrate From Natural Dietary Sources on Arterial Stiffness and Blood Pressures in Healthy Individuals

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this study is to evaluate the acute effect of a meal high in dietary nitrates on aortic augmentation index, brachial and aortic blood pressures, and subendocardial viability ration (SEVR).

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Detailed Description

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Hypertension has become a common medical condition worldwide, raising public concern regarding the accompanying increase in cardiovascular disease risk and other health risks. Targets for optimal blood pressure are often unmet by conventional pharmaceutical therapies; consequently, complementary and alternative medicines are increasing in popularity among patients wishing to better manage their BP. In the case of hypertension, endothelial dysfunction and cardiovascular disease, a decline in the ability of blood vessels to dilate in response to shear stress is a major contributor to vascular pathology. At the core of these conditions is a decreased ability to synthesize nitric oxide, a potent vasodilatory agent. The proposed study will examine whether or not increasing the intake of dietary nitrate, which can be converted to nitric oxide endogenously, can improve three indices of vascular function that are validated risk factors for CVD: arterial stiffness, as measured by aortic augmentation index (AIx), aortic BP and brachial BP.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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High nitrate dietary source

556 grams of high nitrate spinach soup that is orally consumed as a single dose for 7 days.

Group Type EXPERIMENTAL

Spinach soup

Intervention Type OTHER

556 g of high Nitrate spinach soup that is orally consumed as a single dose for 7 days

No Nitrate dietary source

556g low nitrate asparagus soup; orally consumed as a single does for 7 days.

Group Type PLACEBO_COMPARATOR

Asparagus soup

Intervention Type OTHER

556 grams of low nitrate asparagus soup that is orally consumed for a period of 7 days as a single does

Interventions

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Spinach soup

556 g of high Nitrate spinach soup that is orally consumed as a single dose for 7 days

Intervention Type OTHER

Asparagus soup

556 grams of low nitrate asparagus soup that is orally consumed for a period of 7 days as a single does

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers aged 18-50
* Must consider themselves to be in good overall health and be free of any conditions or illnesses Women must be post-menopausal or not pregnant.
* Body mass index (BMI) must be \<30kg/m\^2.
* Normotensive, as defined by brachial SBP \<140mmHg and DBP \<90mmHg
* Subjects must also be willing to stop using mouthwash for the duration of their participation in the study.

Exclusion Criteria

* Women of childbearing age may not be pregnant, planning to become pregnant, or breastfeeding at the time of the study
* BMI \>30kg/m\^2
* Hypertensive as defined by brachial SBP \>140mmHg and/or DBP \>90mmHg
* Allergy or sensitivity to the study product, reference therapy or nitrates
* Having any gastrointestinal complication or condition
* Chronic use of medications such as prescription NSAIDs, antacids, blood-thinners, hypertensive medications, medications affecting NO synthesis such as Viagra, and use of antibiotics within one month of the study start
* Individuals who are involved in another clinical trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes