Effect of Black Tea on Vascular Function (Heraclitus)

Unilever

Status: Completed

Conditions: Vascular Function

Treatments: Other: Positive control; Other: Black tea extract; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01945970

REF-BEV-1134

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 30 patients

Sex: Male

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups, including a placebo group

Black tea extract

Experimental group

Description:

Spray dried aqueous extract of a representative batch of black tea

Treatment:

Other: Black tea extract

Positive control

Active Comparator group

Description:

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

Treatment:

Other: Positive control

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo