Status:
UNKNOWN
Dietary Nitrate on Blood Pressure and Cardiovascular Disease Risk Factors
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Hypertension
Blood Pressure, High
Eligibility:
All Genders
30-60 years
Phase:
PHASE3
Brief Summary
The project aims to determine the effect of a high-nitrate dietary intervention on blood pressure and markers of vascular function compared to a low-nitrate intervention in people with elevated blood ...
Detailed Description
Diets rich in fruits and in particular, vegetables, reduce blood pressure (BP) and the risk of cardiovascular events. Increasingly, attention is being given to high-nitrate containing vegetables, with...
Eligibility Criteria
Inclusion
- BMI 18.5-35 kg/m2
- Seated systolic blood pressure ≥130 and \<160 mmHg
Exclusion
- current use of antihypertensive agents
- history of major cardiovascular events in the last 1 year (stroke or myocardial infarction)
- stage II hypertension as per JNC7 criteria (systolic BP/ diastolic BP ≥160/100 mmHg) - angina pectoris
- gastrointestinal (i.e. inflammatory bowel disease, celiac), liver or kidney disease
- cardiac condition that compromises normal function (e.g. mitral valve disease, heart failure)
- serum triglyceride \>4.5mmol/L
- major disability or disorder requiring continuous medical attention
- planned initiation in antihypertensive therapy
- herb or supplement use that may affect primary outcome
- consuming \>3 servings of vegetables/day (based on semi-quantitative food frequency questionnaire)
- alcohol use \>2 drinks/day
- chronic or prescribed use of medications including prescription NSAIDs, antacids, warfarin, medications affecting NO synthesis (ie. sildenafil, organic nitrates, etc)
- use of antibiotics within 3-months of the study start
- participants should also be willing to refrain from using mouthwash (ie chlorhexidine) for the duration of their participation in the study
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03478631
Start Date
August 1 2018
End Date
August 1 2020
Last Update
March 29 2018
Active Locations (1)
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1
Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8