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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-05-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Nutrition intervention study with a control

Group Type PLACEBO_COMPARATOR

Nutrition intervention study with a control

Intervention Type 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.

Tea extract

Nutrition intervention study with a black tea extract

Group Type EXPERIMENTAL

Nutrition intervention study with a black tea extract

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Black tea extract Control

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes