Trial Outcomes & Findings for Efficacy of Brooke Bond Black Tea Extract on Flow Mediated Dilation in Indian Males (NCT NCT01561300)
NCT ID: NCT01561300
Last Updated: 2017-04-05
Results Overview
Change in flow mediated dilation (FMD) due to tea consumption when compared to control. FMD measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (baseline) * 5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease * 4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion
COMPLETED
NA
30 participants
Baseline day 1 to 2 hours post consumption on day 8.
2017-04-05
Participant Flow
Forty five subjects were invited for screening. Two subjects did not come for the screening, three subjects were not willing to participate and three subjects did not fulfil the inclusion criteria. Of the 37 subjects that fulfilled all inclusion an exclusion criteria 30 were invited to participate.
Thirty subjects meeting all criteria were randomised over the two arms
Participant milestones
| Measure |
Control, Then Washout, Then Tea
Subjects first received Control for one week with Flow Mediated Dilation (FMD) measurements on day 1 and day 8. After a washout of one week (day 8-15) they received Tea for one week with FMD measurements at day 16 and day 22. All FMD measurements were done in a fasted state just before test product intake and exactly 2 hours after test product intake.
|
Tea, Then Wash Out, Then Control
Subjects first received Tea for one week with with Flow Mediated Dilation (FMD) measurements on day 1 and day 8. After a washout of one week (day 8-15) they received Control for one week with FMD measurements at day 16 and day 22. All FMD measurements were done in a fasted state just before test product intake and exactly 2 hours after test product intake.
|
|---|---|---|
|
Run in on Placebo
STARTED
|
15
|
15
|
|
Run in on Placebo
COMPLETED
|
14
|
15
|
|
Run in on Placebo
NOT COMPLETED
|
1
|
0
|
|
First Intervention
STARTED
|
14
|
15
|
|
First Intervention
COMPLETED
|
14
|
15
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout on Placebo
STARTED
|
14
|
15
|
|
Washout on Placebo
COMPLETED
|
14
|
15
|
|
Washout on Placebo
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
14
|
15
|
|
Second Intervention
COMPLETED
|
14
|
15
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Control, Then Washout, Then Tea
Subjects first received Control for one week with Flow Mediated Dilation (FMD) measurements on day 1 and day 8. After a washout of one week (day 8-15) they received Tea for one week with FMD measurements at day 16 and day 22. All FMD measurements were done in a fasted state just before test product intake and exactly 2 hours after test product intake.
|
Tea, Then Wash Out, Then Control
Subjects first received Tea for one week with with Flow Mediated Dilation (FMD) measurements on day 1 and day 8. After a washout of one week (day 8-15) they received Control for one week with FMD measurements at day 16 and day 22. All FMD measurements were done in a fasted state just before test product intake and exactly 2 hours after test product intake.
|
|---|---|---|
|
Run in on Placebo
Adverse Event
|
1
|
0
|
Baseline Characteristics
Efficacy of Brooke Bond Black Tea Extract on Flow Mediated Dilation in Indian Males
Baseline characteristics by cohort
| Measure |
Study Population
n=30 Participants
All participants who were randomised
|
|---|---|
|
Age, Continuous
Age
|
36 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
India
|
30 participants
n=99 Participants
|
|
Body Mass Index
|
23.2 kg/m^2
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline day 1 to 2 hours post consumption on day 8.Population: Per protocol based on the full data set excluding one subject who did produce relevant data (AE) and three subjects who were removed during blind review (operator comments, hypertension and increase in body weight). Single data points were removed for 6 subjects (all single data points) based on operator comments.
Change in flow mediated dilation (FMD) due to tea consumption when compared to control. FMD measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (baseline) * 5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease * 4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion
Outcome measures
| Measure |
Tea Beverage
n=27 Participants
Participants when they received tea
|
Control Beverage
n=27 Participants
Participants when they received control
|
|---|---|---|
|
'Acute-upon-chronic Effect' of Tea vs Control
|
8.03 percentage of change in diameter
Interval 6.95 to 9.12
|
9.03 percentage of change in diameter
Interval 8.01 to 10.05
|
SECONDARY outcome
Timeframe: From baseline on day 1 to 2 hours post consumption on day 1Population: Per protocol based on the full data set excluding one subject who did produce relevant data (AE) and three subjects who were removed during blind review (operator comments, hypertension and increase in body weight). Single data points were removed for 6 subjects (all single data points) based on operator comments.
Change in flow mediated dilation due to tea consumption when compared to control. FMD measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (baseline) * 5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease * 4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion
Outcome measures
| Measure |
Tea Beverage
n=27 Participants
Participants when they received tea
|
Control Beverage
n=27 Participants
Participants when they received control
|
|---|---|---|
|
Acute Effect of Tea vs Control
|
8.44 percent change in flow mediated dilation
Interval 7.08 to 9.79
|
8.82 percent change in flow mediated dilation
Interval 7.52 to 10.09
|
SECONDARY outcome
Timeframe: From baseline at day 1 to baseline on day 8Population: Per protocol based on the full data set excluding one subject who did produce relevant data (AE) and three subjects who were removed during blind review (operator comments, hypertension and increase in body weight). Single data points were removed for 6 subjects (all single data points) based on operator comments.
Change in flow mediated dilation (FMD) due to tea consumption when compared to control. FMD measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (baseline) * 5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease * 4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion
Outcome measures
| Measure |
Tea Beverage
n=27 Participants
Participants when they received tea
|
Control Beverage
n=27 Participants
Participants when they received control
|
|---|---|---|
|
Chronic Effect of Tea vs Control
|
9.19 Percentage change in flow mediated dilat
Interval 8.28 to 10.09
|
9.39 Percentage change in flow mediated dilat
Interval 8.51 to 10.27
|
Adverse Events
Tea Extract
Control
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tea Extract
n=29 participants at risk
Subjects when they consumed tea extract for one week
|
Control
n=29 participants at risk
Subjects when they consumed control for one week
|
Placebo
n=30 participants at risk
Subjects when they consumed placebo for 6 days during the run in and during 7 days during the washout
|
|---|---|---|---|
|
Cardiac disorders
Hypertension
|
0.00%
0/29
|
0.00%
0/29
|
3.3%
1/30 • Number of events 1
|
|
Infections and infestations
Upper restiratory tract infection
|
0.00%
0/29
|
3.4%
1/29 • Number of events 1
|
3.3%
1/30 • Number of events 1
|
|
Gastrointestinal disorders
Increased ferquency of stool
|
3.4%
1/29 • Number of events 1
|
0.00%
0/29
|
0.00%
0/30
|
|
Renal and urinary disorders
Blood in urine
|
0.00%
0/29
|
0.00%
0/29
|
3.3%
1/30 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place