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| Name | Class |
|---|---|
| Sprim Advanced Life Sciences | OTHER |
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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 (FMD).
The current study tests a specific Black tea extract against a placebo in population that has previously show to be sensitive to the effect of black tea on Flow Mediated dilation. A tea extract that has previously been shown to improve FMD is included as the positive control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Black tea extract | Experimental | Spray dried aqueous extract of a representative batch of black tea |
|
| Positive control | Active Comparator | Spray dried aqueous extract of a batch of tea extract that has shown to improve FMD previously |
|
| Placebo | Placebo Comparator | Food grade colouring, artificial tea flavour and an amount of caffeine matched to the caffeine in the Black tea extract |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Black tea extract | Other | Black tea extract |
| |
| Positive control |
| Measure | Description | Time Frame |
|---|---|---|
| Flow Mediated Dilation, Acute-upon-chronic, Black Tea | Flow mediated dilation (FMD) measurement included the following steps:
| From before consumption on day 1 to 2 hours post consumption on day 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Flow Mediated Dilation, Acute, Black Tea | Flow mediated dilation (FMD) measurement included the following steps:
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure, Black Tea | Change in Systolic blood pressure | From before consumption on day 1 to before consumption on day 8 |
| Diastolic Blood Pressure Black Tea | Change in Diastolic blood pressure |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorenzo Ghiadoni, MD | University of Pisa, Internal medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria Pisana, Centro di Farmacologia Clinicaper la Sperimentazione dei Farmaci | Pisa | Italy |
30 subjects randomised
30 suitable subjects recruited from database
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| ID | Title | Description |
|---|---|---|
| FG000 | Black Tea - Positive Control - Placebo | Subjects treated in the order Black tea - wash out- Positive control - wash out - Placebo. Treatments each lasted one week and were separated by a one week washout. |
| FG001 | Black Tea - Placebo - Positive Control | Subjects treated in the order Black tea - wash out- Placebo control - wash out - Positive control. Treatments each lasted one week and were separated by a one week washout. |
| FG002 | Positive Control - Black Tea - Placebo | Subjects treated in the order Positive control - wash out - Black tea - wash out - Placebo. Treatments each lasted one week and were separated by a one week washout. |
| FG003 | Positive Control - Placebo - Black Tea | Subjects treated in the order Positive control - wash out - Placebo - wash out - Black tea. Treatments each lasted one week and were separated by a one week washout. |
| FG004 | Placebo- Positive Control - Black Tea | Subjects treated in the order Placebo - wash out - Positive control - wash out- Black tea. Treatments each lasted one week and were separated by a one week washout. |
| FG005 | Placebo - Black Tea - Positive Control | Subjects treated in the order Placebo - wash out - Black tea - wash out- Positive control. Treatments each lasted one week and were separated by a one week washout. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Cross over study where all subjects recieved all treatments
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Subjects | All six treatment orders combined |
| 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, Acute-upon-chronic, Black Tea | Flow mediated dilation (FMD) measurement included the following steps:
| Intention to treat | Posted | Least Squares Mean | Standard Deviation | percentage of flow mediated dilation | From before consumption on day 1 to 2 hours post consumption on day 8. |
|
Three periods of one week intervention
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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 | Black Tea Extract | Spray dried aqueous extract of a representative batch of black tea |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Theo Mulder | Unilever R&D Research Vlaardingen | +31 10 460 8315 | theo.mulder@gmail.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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| Other |
Positive control |
|
| Placebo | Other | Placebo |
|
| From before consumption on day 1 to 2 hours post consumption on day 1 |
| Flow Mediated Dilation, Chronic, Black Tea | Flow mediated dilation (FMD) measurement included the following steps:
| From before consumption day 1 to before consumption day 8. |
| Flow Mediated Dilation, Acute-upon-chronic, Positive Control | Flow mediated dilation (FMD) measurement included the following steps:
| From before consumption on day 1 to 2 hours post consumption on day 8 |
| Flow Mediated Dilation, Acute, Positive Control | Flow mediated dilation (FMD) measurement included the following steps:
| From before consumption on day 1 to 2 hours post consumption on day 1 |
| Flow Mediated Dilation, Chronic, Positive Control | Flow mediated dilation (FMD) measurement included the following steps:
| From before consumption on day 1 to before consumption day 8 |
| From before consumption on day 1 to before consumption day 8 |
| Systolic Blood Pressure, Positive Control | Change in systolic blood pressure | From before consumption (baseline) day 1 to before consumption day 8 |
| Diastolic Blood Pressure, Positive Control | Change in Diastolic Blood pressure | From before consumption on day 1 to before consumption day 8 |
| Endothelium Independent Dilation, Acute-upon-chronic, Black Tea | FMD measurement included the following steps:
| From before consumption on day 1 to 2 hours post consumption on day 8 |
| Endothelium Independent Dilation, Chronic, Black Tea | Flow mediated dilation (FMD) measurement included the following steps:
| From before consumption on day 1 to before consumption day 8 |
| Endothelium-Independent Dilation, Acute, Black Tea | Flow mediated dilation (FMD) measurement included the following steps:
| From before consumption on day 1 to 2 hours post consumption on day 1 |
| Endothelium Independent Dilation, Acute-upon-chronic, Positive Control | Flow mediated dilation (FMD) measurement included the following steps:
| From before consumption on day 1 to 2 hours post consumption on day 8 |
| Endothelium Independent Dilation, Chronic, Positive Control | Flow mediated dilation (FMD) measurement included the following steps:
| From before consumption on day 1 to before consumption day 8 |
| Endothelium Independent Dilation, Acute, Positive Control | Flow mediated dilation (FMD) measurement included the following steps:
| From before consumption on day 1 to 2 hours post consumption on day 1 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Black Tea Beverage |
Participant when they received Back Tea |
| OG001 | Placebo Beverage | Participants when the received Placebo |
|
|
|
| Secondary | Flow Mediated Dilation, Acute, Black Tea | Flow mediated dilation (FMD) measurement included the following steps:
| Intention to treat | Posted | Least Squares Mean | Standard Deviation | percentage of flow mediated dilation | From before consumption on day 1 to 2 hours post consumption on day 1 |
|
|
|
|
| Secondary | Flow Mediated Dilation, Chronic, Black Tea | Flow mediated dilation (FMD) measurement included the following steps:
| Posted | Least Squares Mean | Standard Deviation | percentage of flow mediated dilation | From before consumption day 1 to before consumption day 8. |
|
|
|
|
| Secondary | Flow Mediated Dilation, Acute-upon-chronic, Positive Control | Flow mediated dilation (FMD) measurement included the following steps:
| Intention to treat | Posted | Least Squares Mean | Standard Deviation | percentage of flow mediated dilation | From before consumption on day 1 to 2 hours post consumption on day 8 |
|
|
|
|
| Secondary | Flow Mediated Dilation, Acute, Positive Control | Flow mediated dilation (FMD) measurement included the following steps:
| Intention to treat | Posted | Mean | Standard Deviation | percentage of flow mediated dilation | From before consumption on day 1 to 2 hours post consumption on day 1 |
|
|
|
|
| Secondary | Flow Mediated Dilation, Chronic, Positive Control | Flow mediated dilation (FMD) measurement included the following steps:
| Intention to treat | Posted | Mean | Standard Deviation | percentage of flow mediated dilation | From before consumption on day 1 to before consumption day 8 |
|
|
|
|
| Other Pre-specified | Systolic Blood Pressure, Black Tea | Change in Systolic blood pressure | Posted | Mean | Standard Deviation | mmHg | From before consumption on day 1 to before consumption on day 8 |
|
|
|
|
| Other Pre-specified | Diastolic Blood Pressure Black Tea | Change in Diastolic blood pressure | Posted | Mean | Standard Deviation | mmHg | From before consumption on day 1 to before consumption day 8 |
|
|
|
|
| Other Pre-specified | Systolic Blood Pressure, Positive Control | Change in systolic blood pressure | Intention to treat | Posted | Mean | Standard Deviation | mmHg | From before consumption (baseline) day 1 to before consumption day 8 |
|
|
|
|
| Other Pre-specified | Diastolic Blood Pressure, Positive Control | Change in Diastolic Blood pressure | Posted | Mean | Standard Deviation | mmHg | From before consumption on day 1 to before consumption day 8 |
|
|
|
|
| Other Pre-specified | Endothelium Independent Dilation, Acute-upon-chronic, Black Tea | FMD measurement included the following steps:
| Intention to treat | Posted | Mean | Standard Deviation | percentage of vascular dilation | From before consumption on day 1 to 2 hours post consumption on day 8 |
|
|
|
|
| Other Pre-specified | Endothelium Independent Dilation, Chronic, Black Tea | Flow mediated dilation (FMD) measurement included the following steps:
| Intention to treat | Posted | Mean | Standard Deviation | percentage of vascular dilation | From before consumption on day 1 to before consumption day 8 |
|
|
|
|
| Other Pre-specified | Endothelium-Independent Dilation, Acute, Black Tea | Flow mediated dilation (FMD) measurement included the following steps:
| Posted | Mean | Standard Deviation | percentage of vascular dilation | From before consumption on day 1 to 2 hours post consumption on day 1 |
|
|
|
|
| Other Pre-specified | Endothelium Independent Dilation, Acute-upon-chronic, Positive Control | Flow mediated dilation (FMD) measurement included the following steps:
| Posted | Mean | Standard Deviation | percentage of vascular dilation | From before consumption on day 1 to 2 hours post consumption on day 8 |
|
|
|
|
| Other Pre-specified | Endothelium Independent Dilation, Chronic, Positive Control | Flow mediated dilation (FMD) measurement included the following steps:
| Intention to treat | Posted | Mean | Standard Deviation | percentage of vascular dilation | From before consumption on day 1 to before consumption day 8 |
|
|
|
|
| Other Pre-specified | Endothelium Independent Dilation, Acute, Positive Control | Flow mediated dilation (FMD) measurement included the following steps:
| Posted | Mean | Standard Deviation | percentage of vascular dilation | From before consumption on day 1 to 2 hours post consumption on day 1 |
|
|
|
|
| 0 |
| 30 |
| 4 |
| 30 |
| EG001 | Positive Control | Spray dried aqueous extract of a batch of tea extract that has shown to improve Flow Mediated Dilation previously | 0 | 30 | 1 | 30 |
| EG002 | Placebo | Food grade colouring, artificial tea flavour and an amount of caffeine matched to the caffeine in the Black tea extract | 0 | 30 | 6 | 30 |
| Syncope | General disorders | Non-systematic Assessment |
|
| Vertigo | General disorders | Non-systematic Assessment |
|
| Influenza | Infections and infestations | Non-systematic Assessment |
|
| Headache | General disorders | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |