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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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 emerging evidence that it might represent a source of vasoactive nitric oxide. Clinical data to date uniformly suggest an acute vasoprotective role of dietary nitrate administration and a BP-lowering effect. Whether the vascular effects extend to long-term intake and in individuals with elevated blood pressure is not well known. The investigators hypothesize that consumption of a dietary intervention high in nitrate from vegetable sources will have a greater effect on BP and related vascular parameters than a similar intervention that is low in dietary nitrates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Nitrate Dehydrated Vegetables | Experimental | 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. |
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| Low-Nitrate Dehydrated Vegetables | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-nitrate dehydrated vegetable powder | Other | A mixed combination of vegetable powders that are naturally high in nitrate content, such as beet, spinach, and kale |
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| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Change in systolic blood pressure vs. control at 16 weeks | Baseline, 8 and16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean 24h and Daytime Ambulatory Systolic, Diastolic and Mean Arterial Blood Pressure | Change in mean 24h and daytime ambulatory systolic, diastolic and mean arterial blood pressure vs. control at 16 weeks | Baseline and 16 weeks |
| Aortic Systolic and Diastolic Blood Pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Symptoms Diary | Record of any adverse symptoms experienced and the level of severity | Screening, baseline, 8 and 16 weeks |
| Aspartate Aminotransferase (AST) | Liver function test |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elena Jovanovski, MSc | Contact | 416 864 6060 | 2597 | JovanovskiE@smh.ca |
| Dandan Li, MSc (c) | Contact | 416 864 6060 | 5527 | LiDand@smh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Vladimir Vuksan, PhD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Nutrition and Risk Factor Modification Centre, St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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The study will be a randomized, double-blind, controlled parallel study. There will be two experimental arms of 16-week duration, in which participants are assigned to test or control arms under free living conditions in an outpatient setting.
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Participants and study coordinators will be blinded to the nature of the treatment allocation. Stratified randomization lists by baseline sex and age will be created.
| Low-nitrate dehydrated vegetable powder | Other | A mixed combination of vegetable powders that are naturally low in nitrate content, such as peas, tomato, broccoli, carrots, and brussel sprouts |
|
Change in aortic systolic and diastolic blood pressure vs. control at 16 weeks |
| Baseline, 8 and 16 weeks |
| Pulse Wave Velocity (PWV) | Change in PWV vs. control at 16 weeks | Baseline and 16 weeks |
| Augmentation Index (AI) | Change in AI vs. control at 16 weeks | Baseline, 8 and 16 weeks |
| High Sensitivity C-reactive protein (hs-CRP) | Change in hs-CRP vs. control at 16 weeks | Baseline and 16 weeks |
| Plasma Lipids | Change in Total-C, LDL-C, HDL-C vs. control at 16 weeks | Baseline and 16 weeks |
| Screening, baseline, 8 and 16 weeks |
| Creatinine | Kidney function test | Screening, baseline, 8 and 16 weeks |
| Sachet Count | Record of the amount of sachets and contents returned | 8 and 16 weeks |
| 7-Day Food Record | Record of food intake 7 days prior to study visit day | Baseline, 8 and 16 weeks |
| Nitrate Food Frequency Questionnaire | Assess consumption of nitrate-rich meats and vegetables | Biweekly (screening, 0,2,4,6,8,10,12,14,16,18 weeks) |
| Habitual Physical Activity Questionnaire | Questions to assess level of physical activity | Baseline, Week 16 |
| Body Weight | Body Weight in kg | Screening, baseline, 8 and 16 weeks |
| 24h Urinary Nitrite and Nitrate levels (exploratory outcome, TBD) | Marker of treatment compliance | 16 weeks |
| 24h Urinary Potassium levels (exploratory outcome, TBD) | Urine samples collected for estimation of potassium intake | 16 weeks |
| 24h Urinary Sodium levels (exploratory outcome, TBD) | Urine samples collected for estimation of sodium intake | 16 weeks |
| Cyclic guanosine monophosphate (cGMP) (exploratory outcome, TBD) | Change in cGMP vs. control at 16 weeks | Baseline and 16 weeks |
| Plasma nitrate/nitrite (exploratory outcome, TBD) | Change in plasma nitrate and nitrite vs. control at 16 weeks | Baseline and 16 weeks |