Vascular Function
Conditions
Keywords
Vascular function, Flow mediated dilation, Tea
Brief summary
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).
Detailed description
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.
Interventions
Sponsors
Sprim Advanced Life Sciences
Unilever R&D
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Apparently healthy male volunteers with no history of cardiovascular disease * Having body mass index (BMI) of between 18.0 and 30.0 kg/m2 (inclusive) * Non-smokers (\> 2 years) * Non-tea drinkers (less or equal 1 cup/week) * Limited alcohol intake (less or equal 21 units/week) * Systolic blood pressure less or equal 160 mmHg and/or diastolic blood pressure less or equal 100 mmHg at screening * Brachial artery can be imaged using ultrasound and at screening FMD value is within the expected range as judged by the PI * Judged to be in good health on the basis of medical history, physical examination and routine laboratory tests (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, glucose, highly sensitive C-reactive protein).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow Mediated Dilation, Acute-upon-chronic, Black Tea | From before consumption on day 1 to 2 hours post consumption on day 8. | Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Flow Mediated Dilation, Acute, Black Tea | From before consumption on day 1 to 2 hours post consumption on day 1 | Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation). |
| Flow Mediated Dilation, Chronic, Black Tea | From before consumption day 1 to before consumption day 8. | Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation). |
| Flow Mediated Dilation, Acute-upon-chronic, Positive Control | From before consumption on day 1 to 2 hours post consumption on day 8 | Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation). |
| Flow Mediated Dilation, Acute, Positive Control | From before consumption on day 1 to 2 hours post consumption on day 1 | Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation). |
| Flow Mediated Dilation, Chronic, Positive Control | From before consumption on day 1 to before consumption day 8 | Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Endothelium-Independent Dilation, Acute, Black Tea | From before consumption on day 1 to 2 hours post consumption on day 1 | Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation). |
| Endothelium Independent Dilation, Acute-upon-chronic, Positive Control | From before consumption on day 1 to 2 hours post consumption on day 8 | Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation). |
| Systolic Blood Pressure, Black Tea | From before consumption on day 1 to before consumption on day 8 | Change in Systolic blood pressure |
| Endothelium Independent Dilation, Acute, Positive Control | From before consumption on day 1 to 2 hours post consumption on day 1 | Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation). |
| Endothelium Independent Dilation, Chronic, Positive Control | From before consumption on day 1 to before consumption day 8 | Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation). |
| Diastolic Blood Pressure Black Tea | From before consumption on day 1 to before consumption day 8 | Change in Diastolic blood pressure |
| Systolic Blood Pressure, Positive Control | From before consumption (baseline) day 1 to before consumption day 8 | Change in systolic blood pressure |
| Diastolic Blood Pressure, Positive Control | From before consumption on day 1 to before consumption day 8 | Change in Diastolic Blood pressure |
| Endothelium Independent Dilation, Acute-upon-chronic, Black Tea | From before consumption on day 1 to 2 hours post consumption on day 8 | FMD measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation). |
| Endothelium Independent Dilation, Chronic, Black Tea | From before consumption on day 1 to before consumption day 8 | Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation). |
Countries
Italy
Participant flow
Recruitment details
30 suitable subjects recruited from database
Pre-assignment details
30 subjects randomised
Participants by arm
| Arm | Count |
|---|---|
| Study Subjects All six treatment orders combined | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Study Subjects |
|---|---|
| Age, Continuous | 43 years |
| Body mass index | 25.0 kg/m^2 STANDARD_DEVIATION 2.4 |
| Diastolic blood pressure | 74 mmHg STANDARD_DEVIATION 8 |
| Region of Enrollment Italy | 30 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 30 Participants |
| Systolic blood pressure | 118 mmHg STANDARD_DEVIATION 12 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 30 | 1 / 30 | 6 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Flow Mediated Dilation, Acute-upon-chronic, Black Tea
Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).
Time frame: From before consumption on day 1 to 2 hours post consumption on day 8.
Population: Intention to treat
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Black Tea Beverage | Flow Mediated Dilation, Acute-upon-chronic, Black Tea | Day 1, before consumption of test product | 4.24 percentage of flow mediated dilation | Standard Deviation 1.57 |
| Black Tea Beverage | Flow Mediated Dilation, Acute-upon-chronic, Black Tea | Day 8, 2 hours post consumption of test product | 4.49 percentage of flow mediated dilation | Standard Deviation 1.88 |
| Placebo Beverage | Flow Mediated Dilation, Acute-upon-chronic, Black Tea | Day 1, before consumption of test product | 4.48 percentage of flow mediated dilation | Standard Deviation 1.92 |
| Placebo Beverage | Flow Mediated Dilation, Acute-upon-chronic, Black Tea | Day 8, 2 hours post consumption of test product | 4.87 percentage of flow mediated dilation | Standard Deviation 1.94 |
p-value: 0.3695% CI: [-1.09, 0.4]Mixed Models Analysis
Secondary
Flow Mediated Dilation, Acute, Black Tea
Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).
Time frame: From before consumption on day 1 to 2 hours post consumption on day 1
Population: Intention to treat
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Black Tea Beverage | Flow Mediated Dilation, Acute, Black Tea | Day 1, 2 hours post consumption of test product | 4.50 percentage of flow mediated dilation | Standard Deviation 1.89 |
| Black Tea Beverage | Flow Mediated Dilation, Acute, Black Tea | Day 1, before consumption of test product | 4.24 percentage of flow mediated dilation | Standard Deviation 1.57 |
| Placebo Beverage | Flow Mediated Dilation, Acute, Black Tea | Day 1, before consumption of test product | 4.48 percentage of flow mediated dilation | Standard Deviation 1.92 |
| Placebo Beverage | Flow Mediated Dilation, Acute, Black Tea | Day 1, 2 hours post consumption of test product | 4.13 percentage of flow mediated dilation | Standard Deviation 1.91 |
p-value: 0.1895% CI: [-0.24, 1.28]Mixed Models Analysis
Secondary
Flow Mediated Dilation, Acute, Positive Control
Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).
Time frame: From before consumption on day 1 to 2 hours post consumption on day 1
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Black Tea Beverage | Flow Mediated Dilation, Acute, Positive Control | Day 1, pre-consumption of test product | 3.28 percentage of flow mediated dilation | Standard Deviation 1.67 |
| Black Tea Beverage | Flow Mediated Dilation, Acute, Positive Control | Day 1, 2 hours post consumption of test product | 4.06 percentage of flow mediated dilation | Standard Deviation 1.78 |
| Placebo Beverage | Flow Mediated Dilation, Acute, Positive Control | Day 1, pre-consumption of test product | 4.48 percentage of flow mediated dilation | Standard Deviation 1.92 |
| Placebo Beverage | Flow Mediated Dilation, Acute, Positive Control | Day 1, 2 hours post consumption of test product | 4.13 percentage of flow mediated dilation | Standard Deviation 1.91 |
p-value: 0.0995% CI: [-0.11, 1.53]Mixed Models Analysis
Secondary
Flow Mediated Dilation, Acute-upon-chronic, Positive Control
Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).
Time frame: From before consumption on day 1 to 2 hours post consumption on day 8
Population: Intention to treat
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Black Tea Beverage | Flow Mediated Dilation, Acute-upon-chronic, Positive Control | Day 1, before consumption of test product | 3.28 percentage of flow mediated dilation | Standard Deviation 1.67 |
| Black Tea Beverage | Flow Mediated Dilation, Acute-upon-chronic, Positive Control | Day 8, 2 hours post consumption of test product | 4.21 percentage of flow mediated dilation | Standard Deviation 1.54 |
| Placebo Beverage | Flow Mediated Dilation, Acute-upon-chronic, Positive Control | Day 1, before consumption of test product | 4.48 percentage of flow mediated dilation | Standard Deviation 1.92 |
| Placebo Beverage | Flow Mediated Dilation, Acute-upon-chronic, Positive Control | Day 8, 2 hours post consumption of test product | 4.87 percentage of flow mediated dilation | Standard Deviation 1.94 |
p-value: 0.2295% CI: [-1.3, 0.31]Mixed Models Analysis
Secondary
Flow Mediated Dilation, Chronic, Black Tea
Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).
Time frame: From before consumption day 1 to before consumption day 8.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Black Tea Beverage | Flow Mediated Dilation, Chronic, Black Tea | Day 1, before consumption of test product | 4.24 percentage of flow mediated dilation | Standard Deviation 1.57 |
| Black Tea Beverage | Flow Mediated Dilation, Chronic, Black Tea | Day 8, before consumption of test product | 3.90 percentage of flow mediated dilation | Standard Deviation 1.67 |
| Placebo Beverage | Flow Mediated Dilation, Chronic, Black Tea | Day 1, before consumption of test product | 4.48 percentage of flow mediated dilation | Standard Deviation 1.92 |
| Placebo Beverage | Flow Mediated Dilation, Chronic, Black Tea | Day 8, before consumption of test product | 4.84 percentage of flow mediated dilation | Standard Deviation 1.96 |
p-value: 0.01495% CI: [-1.59, -0.19]Mixed Models Analysis
Secondary
Flow Mediated Dilation, Chronic, Positive Control
Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).
Time frame: From before consumption on day 1 to before consumption day 8
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Black Tea Beverage | Flow Mediated Dilation, Chronic, Positive Control | Day 1, pre-consumption of test product | 3.28 percentage of flow mediated dilation | Standard Deviation 1.67 |
| Black Tea Beverage | Flow Mediated Dilation, Chronic, Positive Control | Day 8, pre-consumption of test product | 4.20 percentage of flow mediated dilation | Standard Deviation 1.65 |
| Placebo Beverage | Flow Mediated Dilation, Chronic, Positive Control | Day 1, pre-consumption of test product | 4.48 percentage of flow mediated dilation | Standard Deviation 1.92 |
| Placebo Beverage | Flow Mediated Dilation, Chronic, Positive Control | Day 8, pre-consumption of test product | 4.84 percentage of flow mediated dilation | Standard Deviation 1.96 |
p-value: 0.3295% CI: [-1.13, 0.37]Mixed Models Analysis
Other Pre-specified
Diastolic Blood Pressure Black Tea
Change in Diastolic blood pressure
Time frame: From before consumption on day 1 to before consumption day 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Black Tea Beverage | Diastolic Blood Pressure Black Tea | Day 1, before consumption of test product | 72.23 mmHg | Standard Deviation 8.57 |
| Black Tea Beverage | Diastolic Blood Pressure Black Tea | Day 8, before consumption of test product | 71.77 mmHg | Standard Deviation 8.2 |
| Placebo Beverage | Diastolic Blood Pressure Black Tea | Day 1, before consumption of test product | 72.80 mmHg | Standard Deviation 8.07 |
| Placebo Beverage | Diastolic Blood Pressure Black Tea | Day 8, before consumption of test product | 72.27 mmHg | Standard Deviation 8.38 |
p-value: 0.6995% CI: [-2.41, 1.62]Mixed Models Analysis
Other Pre-specified
Diastolic Blood Pressure, Positive Control
Change in Diastolic Blood pressure
Time frame: From before consumption on day 1 to before consumption day 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Black Tea Beverage | Diastolic Blood Pressure, Positive Control | Day 1, before consumption of test product | 72.00 mmHg | Standard Deviation 8.18 |
| Black Tea Beverage | Diastolic Blood Pressure, Positive Control | Day 8, before consumption of test product | 72.98 mmHg | Standard Deviation 7.28 |
| Placebo Beverage | Diastolic Blood Pressure, Positive Control | Day 1, before consumption of test product | 72.80 mmHg | Standard Deviation 8.07 |
| Placebo Beverage | Diastolic Blood Pressure, Positive Control | Day 8, before consumption of test product | 72.27 mmHg | Standard Deviation 8.38 |
p-value: 0.3995% CI: [-1.15, 2.88]Mixed Models Analysis
Other Pre-specified
Endothelium-Independent Dilation, Acute, Black Tea
Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).
Time frame: From before consumption on day 1 to 2 hours post consumption on day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Black Tea Beverage | Endothelium-Independent Dilation, Acute, Black Tea | Day 1, before consumption of test product | 9.55 percentage of vascular dilation | Standard Deviation 3.81 |
| Black Tea Beverage | Endothelium-Independent Dilation, Acute, Black Tea | Day 1, 2 hours post consumption of test product | 8.48 percentage of vascular dilation | Standard Deviation 3.66 |
| Placebo Beverage | Endothelium-Independent Dilation, Acute, Black Tea | Day 1, before consumption of test product | 9.67 percentage of vascular dilation | Standard Deviation 3.37 |
| Placebo Beverage | Endothelium-Independent Dilation, Acute, Black Tea | Day 1, 2 hours post consumption of test product | 8.28 percentage of vascular dilation | Standard Deviation 3.16 |
Comparison: Subject as random factor, baseline same period and mean baseline in both periods as covariates, and treatment, operator, and period as fixed effectsp-value: 0.7495% CI: [-1.11, 1.54]Mixed Models Analysis
Other Pre-specified
Endothelium Independent Dilation, Acute, Positive Control
Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).
Time frame: From before consumption on day 1 to 2 hours post consumption on day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Black Tea Beverage | Endothelium Independent Dilation, Acute, Positive Control | Day 1, before consumption of test product | 10.05 percentage of vascular dilation | Standard Deviation 4.08 |
| Black Tea Beverage | Endothelium Independent Dilation, Acute, Positive Control | Day 1, 2 hours post consumption of test product | 8.74 percentage of vascular dilation | Standard Deviation 2.95 |
| Placebo Beverage | Endothelium Independent Dilation, Acute, Positive Control | Day 1, before consumption of test product | 9.67 percentage of vascular dilation | Standard Deviation 3.37 |
| Placebo Beverage | Endothelium Independent Dilation, Acute, Positive Control | Day 1, 2 hours post consumption of test product | 8.28 percentage of vascular dilation | Standard Deviation 3.16 |
p-value: 0.5595% CI: [-0.93, 1.73]Mixed Models Analysis
Other Pre-specified
Endothelium Independent Dilation, Acute-upon-chronic, Black Tea
FMD measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).
Time frame: From before consumption on day 1 to 2 hours post consumption on day 8
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Black Tea Beverage | Endothelium Independent Dilation, Acute-upon-chronic, Black Tea | Day 1, before consumption of test product | 9.55 percentage of vascular dilation | Standard Deviation 3.81 |
| Black Tea Beverage | Endothelium Independent Dilation, Acute-upon-chronic, Black Tea | Day 8, 2 hours post consumption of test product | 9.02 percentage of vascular dilation | Standard Deviation 3.43 |
| Placebo Beverage | Endothelium Independent Dilation, Acute-upon-chronic, Black Tea | Day 1, before consumption of test product | 9.67 percentage of vascular dilation | Standard Deviation 3.37 |
| Placebo Beverage | Endothelium Independent Dilation, Acute-upon-chronic, Black Tea | Day 8, 2 hours post consumption of test product | 9.28 percentage of vascular dilation | Standard Deviation 2.73 |
p-value: 0.7495% CI: [-1.75, 1.24]Mixed Models Analysis
Other Pre-specified
Endothelium Independent Dilation, Acute-upon-chronic, Positive Control
Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).
Time frame: From before consumption on day 1 to 2 hours post consumption on day 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Black Tea Beverage | Endothelium Independent Dilation, Acute-upon-chronic, Positive Control | Day 1, before consumption of test product | 10.05 percentage of vascular dilation | Standard Deviation 4.08 |
| Black Tea Beverage | Endothelium Independent Dilation, Acute-upon-chronic, Positive Control | Day 8, 2 hours post consumption of test product | 8.96 percentage of vascular dilation | Standard Deviation 3.69 |
| Placebo Beverage | Endothelium Independent Dilation, Acute-upon-chronic, Positive Control | Day 1, before consumption of test product | 9.67 percentage of vascular dilation | Standard Deviation 3.37 |
| Placebo Beverage | Endothelium Independent Dilation, Acute-upon-chronic, Positive Control | Day 8, 2 hours post consumption of test product | 9.28 percentage of vascular dilation | Standard Deviation 2.73 |
p-value: 0.6695% CI: [-1.84, 1.17]Mixed Models Analysis
Other Pre-specified
Endothelium Independent Dilation, Chronic, Black Tea
Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).
Time frame: From before consumption on day 1 to before consumption day 8
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Black Tea Beverage | Endothelium Independent Dilation, Chronic, Black Tea | Day 1, before consumption of test product | 9.55 percentage of vascular dilation | Standard Deviation 3.81 |
| Black Tea Beverage | Endothelium Independent Dilation, Chronic, Black Tea | Day 8, before consumption of test product | 9.86 percentage of vascular dilation | Standard Deviation 4.58 |
| Placebo Beverage | Endothelium Independent Dilation, Chronic, Black Tea | Day 1, before consumption of test product | 9.67 percentage of vascular dilation | Standard Deviation 3.37 |
| Placebo Beverage | Endothelium Independent Dilation, Chronic, Black Tea | Day 8, before consumption of test product | 10.51 percentage of vascular dilation | Standard Deviation 4.16 |
p-value: 0.4195% CI: [-2.12, 0.88]Mixed Models Analysis
Other Pre-specified
Endothelium Independent Dilation, Chronic, Positive Control
Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).
Time frame: From before consumption on day 1 to before consumption day 8
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Black Tea Beverage | Endothelium Independent Dilation, Chronic, Positive Control | Day 1, before consumption of test product | 10.05 percentage of vascular dilation | Standard Deviation 4.08 |
| Black Tea Beverage | Endothelium Independent Dilation, Chronic, Positive Control | Day 8, before consumption of test product | 9.41 percentage of vascular dilation | Standard Deviation 3.98 |
| Placebo Beverage | Endothelium Independent Dilation, Chronic, Positive Control | Day 1, before consumption of test product | 9.67 percentage of vascular dilation | Standard Deviation 3.37 |
| Placebo Beverage | Endothelium Independent Dilation, Chronic, Positive Control | Day 8, before consumption of test product | 10.51 percentage of vascular dilation | Standard Deviation 4.16 |
p-value: 0.1195% CI: [-2.7, 0.3]Mixed Models Analysis
Other Pre-specified
Systolic Blood Pressure, Black Tea
Change in Systolic blood pressure
Time frame: From before consumption on day 1 to before consumption on day 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Black Tea Beverage | Systolic Blood Pressure, Black Tea | Day 1, before consumption of test product | 111.7 mmHg | Standard Deviation 11.45 |
| Black Tea Beverage | Systolic Blood Pressure, Black Tea | Day 8, before consumption of test product | 113.7 mmHg | Standard Deviation 11.84 |
| Placebo Beverage | Systolic Blood Pressure, Black Tea | Day 1, before consumption of test product | 112.1 mmHg | Standard Deviation 10.75 |
| Placebo Beverage | Systolic Blood Pressure, Black Tea | Day 8, before consumption of test product | 111.8 mmHg | Standard Deviation 10.41 |
p-value: 0.1495% CI: [-0.61, 4.39]Mixed Models Analysis
Other Pre-specified
Systolic Blood Pressure, Positive Control
Change in systolic blood pressure
Time frame: From before consumption (baseline) day 1 to before consumption day 8
Population: Intention to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Black Tea Beverage | Systolic Blood Pressure, Positive Control | Day 1, before consumption of test product | 112.9 mmHg | Standard Deviation 12.9 |
| Black Tea Beverage | Systolic Blood Pressure, Positive Control | Day 8, before consumption of test product | 112.3 mmHg | Standard Deviation 10.05 |
| Placebo Beverage | Systolic Blood Pressure, Positive Control | Day 1, before consumption of test product | 112.1 mmHg | Standard Deviation 10.75 |
| Placebo Beverage | Systolic Blood Pressure, Positive Control | Day 8, before consumption of test product | 111.8 mmHg | Standard Deviation 10.41 |
p-value: 0.7295% CI: [-2.06, 2.95]Mixed Models Analysis