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We are interested in the effect of diet on blood pressure. Our previous research has shown that beetroot juice lowers blood pressure in healthy people. We now want to see if beetroot juice has this effect in people with high blood pressure. Beetroot juice is naturally rich in nitrate (also found in most other vegetables but particularly in green leafy vegetables). We think that it is the nitrate that lowers the blood pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Beetroot Juice | Experimental |
| |
| Nitrate-free beetroot juice | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| beetroot juice | Dietary Supplement | Beetroot juice 4 weeks 250ml daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Change in Clinic Systolic Blood Pressure From Baseline | 4 weeks | |
| Difference in Change in Clinic Diastolic Blood Pressure From Baseline | 4 weeks | |
| Difference in Change in Ambulatory Systolic Blood Pressure From Baseline | 4 weeks | |
| Difference in Change in Ambulatory Diastolic Blood Pressure From Baseline | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Change in Plasma Nitrite Concentration From Baseline | 4 weeks | |
| Difference in Change in Endothelial Function From Baseline | as measured by flow-mediated dilatation [%change in diameter of vessel] - an increase in diameter demonstrates an improvement in endothelial function |
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Inclusion Criteria:
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
and either of the following categories of blood pressure
Category 1---Pre---hypertensive SBP 130---139 or DBP 85---89 on no antihypertensives and will not commence antihypertensives during the course of the study.
Category 2---Grade 1 hypertensive SBP 140---159 or DBP 90---99 on no anti---hypertensives, no target organ damage (TOD), low cardiovascular disease (CVD) risk Category 3---Uncontrolled severe resistant (Grade 3) hypertensive with evidence of difficulty treating to target BP (140/85 or 130/80), with satisfactory adherence to at least one antihypertensive, but insufficient efficacy or intolerance of medications. (Category 3 patients may also be on aspirin and/or a stable dose of cholesterol---lowering medications e.g statins).
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
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| Name | Affiliation | Role |
|---|---|---|
| Amrita Ahluwalia | Queen Mary University London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary University London | London | London | EC1M 6BQ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25421976 | Derived | Kapil V, Khambata RS, Robertson A, Caulfield MJ, Ahluwalia A. Dietary nitrate provides sustained blood pressure lowering in hypertensive patients: a randomized, phase 2, double-blind, placebo-controlled study. Hypertension. 2015 Feb;65(2):320-7. doi: 10.1161/HYPERTENSIONAHA.114.04675. Epub 2014 Nov 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Beetroot Juice | Beetroot juice, 4 weeks 250ml daily |
| FG001 | Nitrate-free Beetroot Juice | Nitrate-free beetroot juice, 4 weeks 250ml daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Beetroot Juice | Beetroot juice 4 weeks 250ml daily |
| BG001 | Nitrate-free Beetroot Juice | Nitrate-free beetroot juice, 4 weeks 250ml daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Change in Clinic Systolic Blood Pressure From Baseline | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
|
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Beetroot Juice | Beetroot juice, 4 weeks 250ml daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Amrita Ahluwalia | Queen Mary University London | 02078825720 | a.ahluwalia@qmul.ac.uk |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Nitrate-free beetroot juice |
| Dietary Supplement |
Nitrate-free beetroot juice 4 weeks 250ml daily |
|
| 4 weeks |
| Difference in Change in Arterial Stiffness From Baseline | carotid-femoral pulse wave velocity [m/s] measured by Vicorder | 4 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Difference in Change in Plasma Nitrite Concentration From Baseline | Posted | Mean | Standard Deviation | umol/L | 4 weeks |
|
|
|
| Secondary | Difference in Change in Endothelial Function From Baseline | as measured by flow-mediated dilatation [%change in diameter of vessel] - an increase in diameter demonstrates an improvement in endothelial function | Posted | Mean | Standard Deviation | % dilatation | 4 weeks |
|
|
|
| Primary | Difference in Change in Clinic Diastolic Blood Pressure From Baseline | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
|
|
|
| Primary | Difference in Change in Ambulatory Systolic Blood Pressure From Baseline | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
|
|
|
| Primary | Difference in Change in Ambulatory Diastolic Blood Pressure From Baseline | Posted | Mean | Standard Deviation | mmHg | 4 weeks |
|
|
|
| Secondary | Difference in Change in Arterial Stiffness From Baseline | carotid-femoral pulse wave velocity [m/s] measured by Vicorder | Posted | Mean | Standard Deviation | m/s | 4 weeks |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Nitrate-free Beetroot Juice | Nitrate-free beetroot juice, 4 weeks 250ml daily | 0 | 32 | 0 | 32 |
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