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Completed

NCT Number: NCT01604993

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

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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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Risk Factor Modification Centre

Toronto, Ontario, M5B 1W8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spinach soup

Other

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

Asparagus soup

Other

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

Primary outcomes

  1. Aortic augmentation index (arterial stiffness)

    Time frame: At each treatment visits, this measurement will be taken in at baseline, 1, 2, and 3 hours post-treatment.

Secondary outcomes

  1. Peripheral (brachial) and central (aortic) systolic and diastolic blood pressure

    Time frame: Brachial blood pressure will be measured at 0 , 1, 2, and 3 hours post -treatmentbaseline and at 1, 2 and 3 hours at every visit.

  2. Subendocardial viability ratio (SEVR)

    Time frame: At 1 hours intervals starting from baseline and ending at 3 hours.

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study title

Acute Effect of Nitrate Supplementation From Natural Dietary Sources on Arterial Stiffness and Aortic and Brachial Blood Pressures: a Double-blind, Placebo-controlled, Randomized, Crossover Clinical Trial in Healthy Adults

Acronym: DNAB

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
May 24, 2012
Registry last updated
Mar 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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