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Effect of Black Tea on Vascular Function (Heraclitus)

Unilever logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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