Acute Effect of Nitrate From Natural Dietary Sources on A... | NCT01604993

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

NCT01604993

Sponsor

Unity Health Toronto

Status

Completed

Last Update Posted

Mar 10, 2014Estimated

Enrollment

31Actual

Phase

Phase 2

Conditions

Healthy

Interventions

Spinach soup
Asparagus soup

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Nov 2012Actual

Completion Date

Oct 2013Actual

First Submitted Date

May 22, 2012

First Submission Date that Met QC Criteria

May 22, 2012

First Posted Date

May 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2014

Last Update Posted Date

Mar 10, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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).

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spinach soup	Other	556 g of high Nitrate spinach soup that is orally consumed as a single dose for 7 days	High nitrate dietary source

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Aortic augmentation index (arterial stiffness)		At each treatment visits, this measurement will be taken in at baseline, 1, 2, and 3 hours post-treatment.

Secondary Outcomes

Measure	Description	Time Frame
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.
Subendocardial viability ratio (SEVR)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vladimir Vuksan, PhD	Risk Factor Modification Centre - St. Michael's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Risk Factor Modification Centre		Toronto	Ontario	M5B 1W8	Canada