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NCT Number: NCT01561300

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

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.

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Key information

Conditions

Healthy

Age range

30 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Lotus Labs Pvt. Ltd.,

Bangalore, Karnataka, 560011, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Black tea extract

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.

Other names: Control

Primary outcomes

  1. '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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Collaborators

  • Clumax Diagnostics, Bangalore, India
  • Lotus Labs Pvt. Ltd, Bangalore, India
  • Quipu S.r.l, Pisa, Italy

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 23, 2012
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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