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

U

Unity Health Toronto

Status and phase

Completed
Phase 2

Conditions

Healthy

Treatments

Other: Spinach soup
Other: Asparagus soup

Study type

Interventional

Funder types

Other

Identifiers

NCT01604993
11216 (Registry Identifier)

Details and patient eligibility

About

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).

Full description

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.

Enrollment

31 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

31 participants in 2 patient groups, including a placebo group

High nitrate dietary source
Experimental group
Description:
556 grams of high nitrate spinach soup that is orally consumed as a single dose for 7 days.
Treatment:
Other: Spinach soup
No Nitrate dietary source
Placebo Comparator group
Description:
556g low nitrate asparagus soup; orally consumed as a single does for 7 days.
Treatment:
Other: Asparagus soup

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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