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

NCT01604993 | Completed Phase 2

• 1 other identifier: 11216
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Keywords

Dietary Nitrates; Arterial Stiffness; Vascular; Blood pressure

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• 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)

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

Study Arms (2)

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

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

Asparagus soup OTHER

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

No Nitrate dietary source

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

Risk Factor Modification Centre

Toronto, Ontario, M5B 1W8, Canada

Location

Study Officials

• Vladimir Vuksan, PhD

  Risk Factor Modification Centre - St. Michael's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2012
• First Posted: May 24, 2012
• Study Start: October 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: October 1, 2013
• Last Updated: March 10, 2014

Record last verified: 2014-03

Locations

CA (1)