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High Nitrate Dehydrated Vegetables for High Blood Pressure
Phase 3
Waitlist Available
Led By Vladimir Vuksan, PhD
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up biweekly (screening, 0,2,4,6,8,10,12,14,16,18 weeks)
Awards & highlights
Study 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 pressure. Half of the participants will receive the high-nitrate dehydrated vegetable intervention, while the other half will receive the low-nitrate dehydrated vegetable intervention.This project will advance the current hypothesis on the therapeutic link between dietary nitrate and high blood pressure, and potentially derive impactful recommendations for individuals at risk of hypertension.
Eligible Conditions
- High Blood Pressure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ biweekly (screening, 0,2,4,6,8,10,12,14,16,18 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~biweekly (screening, 0,2,4,6,8,10,12,14,16,18 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Systolic Blood Pressure
Secondary outcome measures
Aortic Systolic and Diastolic Blood Pressure
Augmentation Index (AI)
High Sensitivity C-reactive protein (hs-CRP)
+3 moreOther outcome measures
24h Urinary Nitrite and Nitrate levels (exploratory outcome, TBD)
24h Urinary Potassium levels (exploratory outcome, TBD)
24h Urinary Sodium levels (exploratory outcome, TBD)
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: High Nitrate Dehydrated VegetablesExperimental Treatment1 Intervention
Participants are given high-nitrate dehydrated vegetable powders contained in opaque sachets. Participants are advised to consume three sachets per day, over the course of three meals, for 16 weeks.
Group II: Low-Nitrate Dehydrated VegetablesActive Control1 Intervention
Participants are given low-nitrate dehydrated vegetable powders contained in three opaque sachets. Participants are advised to consume three sachets per day, over the course of three meals, for 16 weeks.
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Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,453,327 Total Patients Enrolled
Unity Health TorontoLead Sponsor
539 Previous Clinical Trials
447,675 Total Patients Enrolled
Vladimir Vuksan, PhDPrincipal InvestigatorUnity Health Toronto
20 Previous Clinical Trials
5,986 Total Patients Enrolled
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