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

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Nutrition intervention study with a black tea extract
Nutrition intervention study with a control
Sponsored by
Unilever R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy focused on measuring Black tea, Flow Mediated Dilation, Vascular function, India

Eligibility Criteria

30 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Lotus Labs Pvt. Ltd.,

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Tea extract

Arm Description

Nutrition intervention study with a control

Nutrition intervention study with a black tea extract

Outcomes

Primary Outcome Measures

'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

Secondary Outcome Measures

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
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

Full Information

First Posted
March 20, 2012
Last Updated
February 16, 2017
Sponsor
Unilever R&D
Collaborators
Lotus Labs Pvt. Ltd, Bangalore, India, Clumax Diagnostics, Bangalore, India, Quipu S.r.l, Pisa, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT01561300
Brief Title
Efficacy of Brooke Bond Black Tea Extract on Flow Mediated Dilation in Indian Males
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unilever R&D
Collaborators
Lotus Labs Pvt. Ltd, Bangalore, India, Clumax Diagnostics, Bangalore, India, Quipu S.r.l, Pisa, Italy

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Black tea, Flow Mediated Dilation, Vascular function, India

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Nutrition intervention study with a control
Arm Title
Tea extract
Arm Type
Experimental
Arm Description
Nutrition intervention study with a black tea extract
Intervention Type
Other
Intervention Name(s)
Nutrition intervention study with a black tea extract
Other Intervention Name(s)
Black tea extract
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Nutrition intervention study with a control
Other Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
'Acute-upon-chronic Effect' of Tea vs Control
Description
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
Time Frame
Baseline day 1 to 2 hours post consumption on day 8.
Secondary Outcome Measure Information:
Title
Acute Effect of Tea vs Control
Description
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
Time Frame
From baseline on day 1 to 2 hours post consumption on day 1
Title
Chronic Effect of Tea vs Control
Description
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
Time Frame
From baseline at day 1 to baseline on day 8

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anisha Pargal, Dr
Organizational Affiliation
Unilever Industries Pvt. Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Lotus Labs Pvt. Ltd.,
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560011
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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