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

This study has been completed.
Sponsor:
Collaborators:
Lotus Labs Pvt. Ltd, Bangalore, India
Clumax Diagnostics, Bangalore, India
Quipu S.r.l, Pisa, Italy
Information provided by (Responsible Party):
Unilever R&D
ClinicalTrials.gov Identifier:
NCT01561300
First received: March 20, 2012
Last updated: February 16, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention
Healthy Other: Nutrition intervention study with a black tea extract Other: Nutrition intervention study with a control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Other
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

Resource links provided by NLM:


Further study details as provided by Unilever R&D:

Primary Outcome Measures:
  • 'Acute-upon-chronic Effect' of Tea vs Control [ Time Frame: Baseline day 1 to 2 hours post consumption on day 8. ]

    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 [ Time Frame: From baseline on day 1 to 2 hours post consumption on day 1 ]

    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 [ Time Frame: From baseline at day 1 to baseline on day 8 ]

    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


Enrollment: 30
Study Start Date: March 2012
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Nutrition intervention study with a control
Other: Nutrition intervention study with a control

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.

Other Name: Control
Experimental: Tea extract
Nutrition intervention study with a black tea extract
Other: Nutrition intervention study with a black tea extract

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.

Other Name: Black tea extract

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.
  Eligibility

Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561300

Locations
India
Lotus Labs Pvt. Ltd.,
Bangalore, Karnataka, India, 560011
Sponsors and Collaborators
Unilever R&D
Lotus Labs Pvt. Ltd, Bangalore, India
Clumax Diagnostics, Bangalore, India
Quipu S.r.l, Pisa, Italy
Investigators
Study Director: Anisha Pargal, Dr Unilever Industries Pvt. Ltd
  More Information

Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01561300     History of Changes
Other Study ID Numbers: FDS-BEV-0284
Study First Received: March 20, 2012
Results First Received: December 21, 2016
Last Updated: February 16, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Unilever R&D:
Black tea
Flow Mediated Dilation
Vascular function
India

Additional relevant MeSH terms:
Dilatation, Pathologic
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 19, 2017