Efficacy of Brooke Bond Black Tea Extract on Flow Mediated Dilation in Indian Males

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Efficacy of Standardized Brooke Bond Black Tea Extract on Flow-Mediated Dilation After an Acute Dose as Well as After One Week of Consumption in Healthy Adult Indian Males

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Nutrition intervention study with a black tea extract
* Other: Nutrition intervention study with a control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male volunteers aged between >_30 _< 50 years of age Body Mass Index (BMI) of >_18 and _< 25.0 kg/m2 Systolic blood pressure >_140 and >_100 mmHg and diastolic blood pressure < 90 and > 70 mmHg Subjects who consume _< 2 cups of coffee per day Subjects who drink tea regularly (>_ 2 cups per day) Apparently healthy, with no reported medical condition which might affect the assessment as judged by the study physician or/and PI No prescribed medical treatment that may affect study parameters as judged by the Study Physician Subject willing to abstain from alcohol on day before and on the day of assessment Willing to sign the informed consent form Exclusion Criteria: Smokers and/or tobacco chewers Those who consume regular alcohol (> 160 ml of alcohol per week) Reported intense sport activities > 10h/week Participating in any other clinical study concurrently or if participated in any study during 2 months preceding the screening visit

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Nutrition intervention study with a control | Other: Nutrition intervention study with a control<br>* 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.<br>* Other names: Control;|
| Experimental: Tea extract<br>Nutrition intervention study with a black tea extract | Other: Nutrition intervention study with a black tea extract<br>* 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.<br>* Other names: Black tea extract;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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: 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 | Baseline day 1 to 2 hours post consumption on day 8. | 

Secondary Outcome Measures

| Outcome Measure | 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: 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 | 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: 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 | From baseline at day 1 to baseline on day 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Black tea, Flow Mediated Dilation, Vascular function, India