Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lotus Labs Pvt. Ltd, Bangalore, India | UNKNOWN |
| Clumax Diagnostics, Bangalore, India | UNKNOWN |
| Quipu S.r.l, Pisa, Italy | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study examines the effect of 1800 mg/day standardized Brooke Bond black tea extract, equivalent to 400 mg flavonoids, on Flow Mediated Dilation in healthy Indian males.
Flow mediated dilation (FMD) is a non-invasive measurement technique performed using ultrasound equipment to measure hyperaemia induced dilation of blood vessels. Evidence from prospective studies suggests that FMD is independently inversely associated with cardiovascular events.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Nutrition intervention study with a control |
|
| Tea extract | Experimental | Nutrition intervention study with a black tea extract |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutrition intervention study with a black tea extract | Other | Tea extract: 1800 mg/day standardized Brooke Bond black tea extract equivalent to 400 mg flavonoids dissolved in 240 ml hot water. Products will be consumed for 8 days. On measurement days tea will be given to the subjects as a single acute dose and 2 grams of sugar will be added. On day 2-7 subjects will consume 3 cups or tea, each prepared with 800 mg product in 80 ml of boiling water and sugar added to subject's taste. First cup of tea will be taken as morning tea, 2nd at breakfast and 3rd in the evening. No milk will be added. |
| Measure | Description | Time Frame |
|---|---|---|
| 'Acute-upon-chronic Effect' of Tea vs Control | Change in flow mediated dilation (FMD) due to tea consumption when compared to control. FMD measurement included the following steps:
| Baseline day 1 to 2 hours post consumption on day 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Effect of Tea vs Control | Change in flow mediated dilation due to tea consumption when compared to control. FMD measurement included the following steps:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anisha Pargal, Dr | Unilever Industries Pvt. Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lotus Labs Pvt. Ltd., | Bangalore | Karnataka | 560011 | India |
Not provided
Not provided
Not provided
Not provided
Not provided
Thirty subjects meeting all criteria were randomised over the two arms
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Run in on Placebo |
|
| ||||||||||||||||||
| First Intervention |
| |||||||||||||||||||
| Washout on Placebo |
| |||||||||||||||||||
| Second Intervention |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Study Population | All participants who were randomised |
| 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 | 'Acute-upon-chronic Effect' of Tea vs Control | Change in flow mediated dilation (FMD) due to tea consumption when compared to control. FMD measurement included the following steps:
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | percentage of change in diameter | Baseline day 1 to 2 hours post consumption on day 8. |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tea Extract | Subjects when they consumed tea extract for one week |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders | Non-systematic Assessment | Subject developed hypertension after being included |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Theo Mulder | Unilever R&D Vlaardingen | +31 10 460 8315 | theo.mulder@unilever.com |
Not provided
| ID | Term |
|---|---|
| D013662 | Tea |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Nutrition intervention study with a control | Other | Control: 1800 mg/day of a powder that gives a flavoured beverage with a color similar to black tea dissolved in 240 ml hot water. Products will be consumed for 8 days. On measurement days control will be given to the subjects as a single acute dose and 2 grams of sugar will be added. On day 2-7 subjects will consume 3 cups of control, each prepared with 800 mg product in 80 ml of boiling water and sugar added to subject's taste. First cup of tea will be taken as morning tea, 2nd at breakfast and 3rd in the evening. No milk will be added. |
|
|
| From baseline on day 1 to 2 hours post consumption on day 1 |
| Chronic Effect of Tea vs Control | Change in flow mediated dilation (FMD) due to tea consumption when compared to control. FMD measurement included the following steps:
| From baseline at day 1 to baseline on day 8 |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Median | Full Range | kg/m^2 |
|
| OG000 |
| Tea Beverage |
Participants when they received tea |
| OG001 | Control Beverage | Participants when they received control |
|
|
|
| Secondary | Acute Effect of Tea vs Control | Change in flow mediated dilation due to tea consumption when compared to control. FMD measurement included the following steps:
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | percent change in flow mediated dilation | From baseline on day 1 to 2 hours post consumption on day 1 |
|
|
|
|
| Secondary | Chronic Effect of Tea vs Control | Change in flow mediated dilation (FMD) due to tea consumption when compared to control. FMD measurement included the following steps:
| 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. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage change in flow mediated dilat | From baseline at day 1 to baseline on day 8 |
|
|
|
|
| 0 |
| 29 |
| 1 |
| 29 |
| EG001 | Control | Subjects when they consumed control for one week | 0 | 29 | 1 | 29 |
| EG002 | Placebo | Subjects when they consumed placebo for 6 days during the run in and during 7 days during the washout | 0 | 30 | 3 | 30 |
|
| Upper restiratory tract infection | Infections and infestations | Non-systematic Assessment | During tea drinking |
|
| Increased ferquency of stool | Gastrointestinal disorders | Non-systematic Assessment |
|
| Blood in urine | Renal and urinary disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |