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

Healthy Clinical Trial

— DNAB  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604993
• Other study ID #: 11216
• Status: Completed
• Phase: Phase 2
• First received: May 22, 2012
• Last updated: March 7, 2014
• Start date: October 2011
• Est. completion date: October 2013

Study information

• Verified date: March 2014
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Spinach soup
556 g of high Nitrate spinach soup that is orally consumed as a single dose for 7 days
• Asparagus soup
556 grams of low nitrate asparagus soup that is orally consumed for a period of 7 days as a single does

Locations

Country	Name	City	State
Canada	Risk Factor Modification Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aortic augmentation index (arterial stiffness)		At each treatment visits, this measurement will be taken in at baseline, 1, 2, and 3 hours post-treatment.	No
Secondary	Peripheral (brachial) and central (aortic) systolic and diastolic blood pressure		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.	No
Secondary	Subendocardial viability ratio (SEVR)		At 1 hours intervals starting from baseline and ending at 3 hours.	No