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| Name | Class |
|---|---|
| King's College London | OTHER |
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Research indicate that people who regularly drink tea have a reduced risk of stroke or heart disease. In a number of studies in which people that normally do not drink showed that their blood vessels function improved when the drunk tea. The current study tests whether a specific black tea improves vessel function in non-tea drinking hypertensive subjects.
Epidemiological studies indicate that regular consumption of three cups of black tea per day reduces the risk of stroke or myocardial infarction. In a number of previous nutrition intervention studies tea has been shown to improve vascular function as assessed by Flow Mediated Dilation in various populations. The current confirmatory study tests a specific black tea against a placebo in a population of in non-tea drinking hypertensive subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tea | Experimental | Black tea |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tea | Other | Single dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Flow Mediated Dilation | Flow mediated dilation (FMD) of the brachial artery was measured using vascular ultra sound and automated edge detection software:
| Before and 2 hours after test product intake |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelium-independent Vasodilation | Endothelium-independent dilation after glyceryl trinitrate defined as maximal percent increase in diameter | 2.5 hours after test product intake |
| Systolic Blood Pressure Supine |
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Inclusion Criteria:
Males and post menopausal (> 1 year) females, not on hormone replacement therapy
Aged >18 and < 65 years
Body mass index (BMI) of >=18.0 and =<35.0 kg/m2
Hypertension as previously diagnosed by primary care or hospital physician.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip Chowienczyk, Professor | Dept Clinical Pharmacology/CRF, St Thomas Hospital, London UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept Clinical Pharmacology/CRF, St Thomas Hospital | London | SE1 7EH | United Kingdom |
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All 30 subjects meeting the inclusion criteria were randomised
53 subjects were screened between August 2014 and and October 2015
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| ID | Title | Description |
|---|---|---|
| FG000 | Tea Then Placebo | Subjects first received a single acute dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar. After a washout of at least 1 week, they received a single acute dose of placebo consisting of tea flavour, colouring and sugar. |
| FG001 | Placebo Then Tea | Subjects first received a single acute dose of placebo consisting of tea flavour, colouring and sugar. After a washout of at least 1 week, they received a single acute dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants who were randomised to either receive Tea first followed by Placebo or Placebo first followed by Tea |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Flow Mediated Dilation | Flow mediated dilation (FMD) of the brachial artery was measured using vascular ultra sound and automated edge detection software:
| All participants who received at least one dose of each intervention and completed all study visits | Posted | Least Squares Mean | Standard Deviation | percentage of change in diameter | Before and 2 hours after test product intake |
|
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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 | Tea Beverage | Participants when they received a single dose of black tea infusion with added sugar |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Theo Mulder | Unilever R&D Vlaardingen | +31 10 460 8315 | theo.mulder@unilever.com |
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| ID | Term |
|---|---|
| D013662 | Tea |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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| Placebo | Other | Placebo: tea flavour, colouring and sugar |
|
Systolic blood pressure measured while lying down
| Before and 110 minutes after test product intake |
| Diastolic Blood Pressure Supine | Diastolic blood pressure measured while lying down | Before and 110 minutes after test product intake |
| Systolic Blood Pressure Sitting | Systolic blood pressure measured while sitting | Before and 90 minutes after test product intake |
| Diastolic Blood Pressure Sitting | Diastolic blood pressure measured while sitting | Before and 90 minutes after test product intake |
| years |
|
| Gender | Count of Participants | Participants |
|
| Body Mass Index | Median | Full Range | kg/m^2 |
|
| Systolic blood pressure | Median | Full Range | mmHg |
|
| Diastolic blood pressure | Median | Full Range | mmHg |
|
| OG001 | Placebo Beverage | Participants when they received a single dose of placebo containing tea flavour, colouring and sugar |
|
|
|
| Secondary | Endothelium-independent Vasodilation | Endothelium-independent dilation after glyceryl trinitrate defined as maximal percent increase in diameter | All participants who received at least one dose of each intervention and completed all study visits | Posted | Least Squares Mean | 95% Confidence Interval | percentage of change in diameter | 2.5 hours after test product intake |
|
|
|
|
| Secondary | Systolic Blood Pressure Supine | Systolic blood pressure measured while lying down | All participants who received at least one dose of each intervention and completed all study visits | Posted | Least Squares Mean | Standard Deviation | mmHg | Before and 110 minutes after test product intake |
|
|
|
|
| Secondary | Diastolic Blood Pressure Supine | Diastolic blood pressure measured while lying down | All participants who received at least one dose of each intervention and completed all study visits | Posted | Least Squares Mean | Standard Deviation | mmHg | Before and 110 minutes after test product intake |
|
|
|
|
| Secondary | Systolic Blood Pressure Sitting | Systolic blood pressure measured while sitting | All participants who received at least one dose of each intervention and completed all study visits | Posted | Least Squares Mean | Standard Deviation | mmHg | Before and 90 minutes after test product intake |
|
|
|
|
| Secondary | Diastolic Blood Pressure Sitting | Diastolic blood pressure measured while sitting | All participants who received at least one dose of each intervention and completed all study visits | Posted | Least Squares Mean | Standard Deviation | mmHg | Before and 90 minutes after test product intake |
|
|
|
|
| 0 |
| 30 |
| 1 |
| 30 |
| EG001 | Placebo Beverage | Participants when they received a single dose of placebo containing tea flavour, colouring and sugar | 0 | 30 | 1 | 30 |
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |