Acute Effect of Nitrate From Natural Dietary Sources on Arterial Stiffness and Blood Pressures in Healthy Individuals (DNAB)
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Health Services Research
|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|
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- Subendocardial viability ratio (SEVR) [ Time Frame: At 1 hours intervals starting from baseline and ending at 3 hours. ] [ Designated as safety issue: No ]
|Study Start Date:||October 2011|
|Study Completion Date:||October 2013|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Experimental: High nitrate dietary source
556 grams of high nitrate spinach soup that is orally consumed as a single dose for 7 days.
Other: Spinach soup
556 g of high Nitrate spinach soup that is orally consumed as a single dose for 7 days
Placebo Comparator: No Nitrate dietary source
556g low nitrate asparagus soup; orally consumed as a single does for 7 days.
Other: Asparagus soup
556 grams of low nitrate asparagus soup that is orally consumed for a period of 7 days as a single does
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604993
|Risk Factor Modification Centre|
|Toronto, Ontario, Canada, M5B 1W8|
|Principal Investigator:||Vladimir Vuksan, PhD||Risk Factor Modification Centre - St. Michael's Hospital|