Trial Outcomes & Findings for Effect of Black Tea on Vascular Function (NCT NCT01945970)
NCT ID: NCT01945970
Last Updated: 2017-03-22
Results Overview
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).
COMPLETED
NA
30 participants
From before consumption on day 1 to 2 hours post consumption on day 8.
2017-03-22
Participant Flow
30 suitable subjects recruited from database
30 subjects randomised
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Black Tea on Vascular Function
Baseline characteristics by cohort
| Measure |
Study Subjects
n=30 Participants
All six treatment orders combined
|
|---|---|
|
Age, Continuous
|
43 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
|
Region of Enrollment
Italy
|
30 Participants
n=99 Participants
|
|
Body mass index
|
25.0 kg/m^2
STANDARD_DEVIATION 2.4 • n=99 Participants
|
|
Systolic blood pressure
|
118 mmHg
STANDARD_DEVIATION 12 • n=99 Participants
|
|
Diastolic blood pressure
|
74 mmHg
STANDARD_DEVIATION 8 • n=99 Participants
|
PRIMARY outcome
Timeframe: From before consumption on day 1 to 2 hours post consumption on day 8.Population: Intention to treat
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).
Outcome measures
| Measure |
Black Tea Beverage
n=30 Participants
Participant when they received Back Tea
|
Placebo Beverage
n=30 Participants
Participants when the received Placebo
|
|---|---|---|
|
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
|
4.48 percentage of flow mediated dilation
Standard Deviation 1.92
|
|
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
|
4.87 percentage of flow mediated dilation
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: From before consumption on day 1 to 2 hours post consumption on day 1Population: Intention to treat
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).
Outcome measures
| Measure |
Black Tea Beverage
n=30 Participants
Participant when they received Back Tea
|
Placebo Beverage
n=30 Participants
Participants when the received Placebo
|
|---|---|---|
|
Flow Mediated Dilation, Acute, Black Tea
Day 1, before consumption of test product
|
4.24 percentage of flow mediated dilation
Standard Deviation 1.57
|
4.48 percentage of flow mediated dilation
Standard Deviation 1.92
|
|
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
|
4.13 percentage of flow mediated dilation
Standard Deviation 1.91
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Black Tea Beverage
n=30 Participants
Participant when they received Back Tea
|
Placebo Beverage
n=30 Participants
Participants when the received Placebo
|
|---|---|---|
|
Flow Mediated Dilation, Chronic, Black Tea
Day 1, before consumption of test product
|
4.24 percentage of flow mediated dilation
Standard Deviation 1.57
|
4.48 percentage of flow mediated dilation
Standard Deviation 1.92
|
|
Flow Mediated Dilation, Chronic, Black Tea
Day 8, before consumption of test product
|
3.90 percentage of flow mediated dilation
Standard Deviation 1.67
|
4.84 percentage of flow mediated dilation
Standard Deviation 1.96
|
SECONDARY outcome
Timeframe: From before consumption on day 1 to 2 hours post consumption on day 8Population: Intention to treat
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).
Outcome measures
| Measure |
Black Tea Beverage
n=30 Participants
Participant when they received Back Tea
|
Placebo Beverage
n=30 Participants
Participants when the received Placebo
|
|---|---|---|
|
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
|
4.48 percentage of flow mediated dilation
Standard Deviation 1.92
|
|
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
|
4.87 percentage of flow mediated dilation
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: From before consumption on day 1 to 2 hours post consumption on day 1Population: Intention to treat
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).
Outcome measures
| Measure |
Black Tea Beverage
n=30 Participants
Participant when they received Back Tea
|
Placebo Beverage
n=30 Participants
Participants when the received Placebo
|
|---|---|---|
|
Flow Mediated Dilation, Acute, Positive Control
Day 1, pre-consumption of test product
|
3.28 percentage of flow mediated dilation
Standard Deviation 1.67
|
4.48 percentage of flow mediated dilation
Standard Deviation 1.92
|
|
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
|
4.13 percentage of flow mediated dilation
Standard Deviation 1.91
|
SECONDARY outcome
Timeframe: From before consumption on day 1 to before consumption day 8Population: Intention to treat
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).
Outcome measures
| Measure |
Black Tea Beverage
n=30 Participants
Participant when they received Back Tea
|
Placebo Beverage
n=30 Participants
Participants when the received Placebo
|
|---|---|---|
|
Flow Mediated Dilation, Chronic, Positive Control
Day 1, pre-consumption of test product
|
3.28 percentage of flow mediated dilation
Standard Deviation 1.67
|
4.48 percentage of flow mediated dilation
Standard Deviation 1.92
|
|
Flow Mediated Dilation, Chronic, Positive Control
Day 8, pre-consumption of test product
|
4.20 percentage of flow mediated dilation
Standard Deviation 1.65
|
4.84 percentage of flow mediated dilation
Standard Deviation 1.96
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From before consumption on day 1 to before consumption on day 8Change in Systolic blood pressure
Outcome measures
| Measure |
Black Tea Beverage
n=30 Participants
Participant when they received Back Tea
|
Placebo Beverage
n=30 Participants
Participants when the received Placebo
|
|---|---|---|
|
Systolic Blood Pressure, Black Tea
Day 1, before consumption of test product
|
111.7 mmHg
Standard Deviation 11.45
|
112.1 mmHg
Standard Deviation 10.75
|
|
Systolic Blood Pressure, Black Tea
Day 8, before consumption of test product
|
113.7 mmHg
Standard Deviation 11.84
|
111.8 mmHg
Standard Deviation 10.41
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From before consumption on day 1 to before consumption day 8Change in Diastolic blood pressure
Outcome measures
| Measure |
Black Tea Beverage
n=30 Participants
Participant when they received Back Tea
|
Placebo Beverage
n=30 Participants
Participants when the received Placebo
|
|---|---|---|
|
Diastolic Blood Pressure Black Tea
Day 1, before consumption of test product
|
72.23 mmHg
Standard Deviation 8.57
|
72.80 mmHg
Standard Deviation 8.07
|
|
Diastolic Blood Pressure Black Tea
Day 8, before consumption of test product
|
71.77 mmHg
Standard Deviation 8.20
|
72.27 mmHg
Standard Deviation 8.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From before consumption (baseline) day 1 to before consumption day 8Population: Intention to treat
Change in systolic blood pressure
Outcome measures
| Measure |
Black Tea Beverage
n=30 Participants
Participant when they received Back Tea
|
Placebo Beverage
n=30 Participants
Participants when the received Placebo
|
|---|---|---|
|
Systolic Blood Pressure, Positive Control
Day 1, before consumption of test product
|
112.9 mmHg
Standard Deviation 12.90
|
112.1 mmHg
Standard Deviation 10.75
|
|
Systolic Blood Pressure, Positive Control
Day 8, before consumption of test product
|
112.3 mmHg
Standard Deviation 10.05
|
111.8 mmHg
Standard Deviation 10.41
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From before consumption on day 1 to before consumption day 8Change in Diastolic Blood pressure
Outcome measures
| Measure |
Black Tea Beverage
n=30 Participants
Participant when they received Back Tea
|
Placebo Beverage
n=30 Participants
Participants when the received Placebo
|
|---|---|---|
|
Diastolic Blood Pressure, Positive Control
Day 1, before consumption of test product
|
72.00 mmHg
Standard Deviation 8.18
|
72.80 mmHg
Standard Deviation 8.07
|
|
Diastolic Blood Pressure, Positive Control
Day 8, before consumption of test product
|
72.98 mmHg
Standard Deviation 7.28
|
72.27 mmHg
Standard Deviation 8.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From before consumption on day 1 to 2 hours post consumption on day 8Population: Intention to treat
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).
Outcome measures
| Measure |
Black Tea Beverage
n=30 Participants
Participant when they received Back Tea
|
Placebo Beverage
n=30 Participants
Participants when the received Placebo
|
|---|---|---|
|
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
|
9.67 percentage of vascular dilation
Standard Deviation 3.37
|
|
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
|
9.28 percentage of vascular dilation
Standard Deviation 2.73
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From before consumption on day 1 to before consumption day 8Population: Intention to treat
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).
Outcome measures
| Measure |
Black Tea Beverage
n=30 Participants
Participant when they received Back Tea
|
Placebo Beverage
n=30 Participants
Participants when the received Placebo
|
|---|---|---|
|
Endothelium Independent Dilation, Chronic, Black Tea
Day 1, before consumption of test product
|
9.55 percentage of vascular dilation
Standard Deviation 3.81
|
9.67 percentage of vascular dilation
Standard Deviation 3.37
|
|
Endothelium Independent Dilation, Chronic, Black Tea
Day 8, before consumption of test product
|
9.86 percentage of vascular dilation
Standard Deviation 4.58
|
10.51 percentage of vascular dilation
Standard Deviation 4.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From before consumption on day 1 to 2 hours post consumption on day 1Flow 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).
Outcome measures
| Measure |
Black Tea Beverage
n=30 Participants
Participant when they received Back Tea
|
Placebo Beverage
n=30 Participants
Participants when the received Placebo
|
|---|---|---|
|
Endothelium-Independent Dilation, Acute, Black Tea
Day 1, before consumption of test product
|
9.55 percentage of vascular dilation
Standard Deviation 3.81
|
9.67 percentage of vascular dilation
Standard Deviation 3.37
|
|
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
|
8.28 percentage of vascular dilation
Standard Deviation 3.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From before consumption on day 1 to 2 hours post consumption on day 8Flow 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).
Outcome measures
| Measure |
Black Tea Beverage
n=30 Participants
Participant when they received Back Tea
|
Placebo Beverage
n=30 Participants
Participants when the received Placebo
|
|---|---|---|
|
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
|
9.67 percentage of vascular dilation
Standard Deviation 3.37
|
|
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
|
9.28 percentage of vascular dilation
Standard Deviation 2.73
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From before consumption on day 1 to before consumption day 8Population: Intention to treat
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).
Outcome measures
| Measure |
Black Tea Beverage
n=30 Participants
Participant when they received Back Tea
|
Placebo Beverage
n=30 Participants
Participants when the received Placebo
|
|---|---|---|
|
Endothelium Independent Dilation, Chronic, Positive Control
Day 1, before consumption of test product
|
10.05 percentage of vascular dilation
Standard Deviation 4.08
|
9.67 percentage of vascular dilation
Standard Deviation 3.37
|
|
Endothelium Independent Dilation, Chronic, Positive Control
Day 8, before consumption of test product
|
9.41 percentage of vascular dilation
Standard Deviation 3.98
|
10.51 percentage of vascular dilation
Standard Deviation 4.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From before consumption on day 1 to 2 hours post consumption on day 1Flow 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).
Outcome measures
| Measure |
Black Tea Beverage
n=30 Participants
Participant when they received Back Tea
|
Placebo Beverage
n=30 Participants
Participants when the received Placebo
|
|---|---|---|
|
Endothelium Independent Dilation, Acute, Positive Control
Day 1, before consumption of test product
|
10.05 percentage of vascular dilation
Standard Deviation 4.08
|
9.67 percentage of vascular dilation
Standard Deviation 3.37
|
|
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
|
8.28 percentage of vascular dilation
Standard Deviation 3.16
|
Adverse Events
Black Tea Extract
Positive Control
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Black Tea Extract
n=30 participants at risk
Spray dried aqueous extract of a representative batch of black tea
|
Positive Control
n=30 participants at risk
Spray dried aqueous extract of a batch of tea extract that has shown to improve Flow Mediated Dilation previously
|
Placebo
n=30 participants at risk
Food grade colouring, artificial tea flavour and an amount of caffeine matched to the caffeine in the Black tea extract
|
|---|---|---|---|
|
Infections and infestations
Pyrexia
|
3.3%
1/30 • Number of events 1 • Three periods of one week intervention
|
0.00%
0/30 • Three periods of one week intervention
|
0.00%
0/30 • Three periods of one week intervention
|
|
General disorders
Syncope
|
0.00%
0/30 • Three periods of one week intervention
|
0.00%
0/30 • Three periods of one week intervention
|
3.3%
1/30 • Number of events 1 • Three periods of one week intervention
|
|
General disorders
Vertigo
|
0.00%
0/30 • Three periods of one week intervention
|
0.00%
0/30 • Three periods of one week intervention
|
3.3%
1/30 • Number of events 1 • Three periods of one week intervention
|
|
Infections and infestations
Influenza
|
0.00%
0/30 • Three periods of one week intervention
|
0.00%
0/30 • Three periods of one week intervention
|
3.3%
1/30 • Number of events 1 • Three periods of one week intervention
|
|
General disorders
Headache
|
3.3%
1/30 • Number of events 1 • Three periods of one week intervention
|
3.3%
1/30 • Number of events 1 • Three periods of one week intervention
|
6.7%
2/30 • Number of events 2 • Three periods of one week intervention
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/30 • Three periods of one week intervention
|
0.00%
0/30 • Three periods of one week intervention
|
3.3%
1/30 • Number of events 1 • Three periods of one week intervention
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • Number of events 1 • Three periods of one week intervention
|
0.00%
0/30 • Three periods of one week intervention
|
0.00%
0/30 • Three periods of one week intervention
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
1/30 • Number of events 1 • Three periods of one week intervention
|
0.00%
0/30 • Three periods of one week intervention
|
0.00%
0/30 • Three periods of one week intervention
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place