Effect of Black Tea on Vascular Function

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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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

2013-09-30

Study Completion Date

2013-12-31

Brief Summary

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Epidemiological studies indicate that regular consumption of three cups of black tea per day reduces the risk of stroke or myocardial infarction. In a number of previous nutrition intervention studies tea has been shown to improve vascular function as assessed by Flow Mediated Dilation (FMD).

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Detailed Description

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The current study tests a specific Black tea extract against a placebo in population that has previously show to be sensitive to the effect of black tea on Flow Mediated dilation. A tea extract that has previously been shown to improve FMD is included as the positive control.

Conditions

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Vascular Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Black tea extract

Spray dried aqueous extract of a representative batch of black tea

Group Type EXPERIMENTAL

Black tea extract

Intervention Type OTHER

Black tea extract

Positive control

Spray dried aqueous extract of a batch of tea extract that has shown to improve FMD previously

Group Type ACTIVE_COMPARATOR

Positive control

Intervention Type OTHER

Positive control

Placebo

Food grade colouring, artificial tea flavour and an amount of caffeine matched to the caffeine in the Black tea extract

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Black tea extract

Intervention Type OTHER

Positive control

Intervention Type OTHER

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Apparently healthy male volunteers with no history of cardiovascular disease
* Having body mass index (BMI) of between 18.0 and 30.0 kg/m2 (inclusive)
* Non-smokers (\> 2 years)
* Non-tea drinkers (less or equal 1 cup/week)
* Limited alcohol intake (less or equal 21 units/week)
* Systolic blood pressure less or equal 160 mmHg and/or diastolic blood pressure less or equal 100 mmHg at screening
* Brachial artery can be imaged using ultrasound and at screening FMD value is within the expected range as judged by the PI
* Judged to be in good health on the basis of medical history, physical examination and routine laboratory tests (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, glucose, highly sensitive C-reactive protein).

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes