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Flow Mediated Dilation in Response to Black Tea

Not Applicable
Completed
Conditions
Vascular Function
Interventions
Other: Placebo
Other: Tea
Registration Number
NCT02273323
Lead Sponsor
Unilever R&D
Brief Summary

Research indicate that people who regularly drink tea have a reduced risk of stroke or heart disease. In a number of studies in which people that normally do not drink showed that their blood vessels function improved when the drunk tea. The current study tests whether a specific black tea improves vessel function in non-tea drinking hypertensive subjects.

Detailed Description

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 in various populations. The current confirmatory study tests a specific black tea against a placebo in a population of in non-tea drinking hypertensive subjects.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
Inclusion Criteria
  • Males and post menopausal (> 1 year) females, not on hormone replacement therapy

  • Aged >18 and < 65 years

  • Body mass index (BMI) of >=18.0 and =<35.0 kg/m2

  • Hypertension as previously diagnosed by primary care or hospital physician.

    • If untreated, office BP between 140/90 mmHg and 160/100 mmHg on screening
    • If treated, a controlled blood pressure (<160/100) on stable medication for at least 4 weeks
Exclusion Criteria
  • Tea drinkers: having typically consumed > 1 cup of black tea per week.
  • Current smoker or has stopped smoking less than 6 months before start of study
  • Self reported alcohol intake of >21 units/week
  • Established cardiovascular disease other than hypertension
  • Clinically significant arrhythmia
  • Diabetes mellitus
  • Chronic Kidney Disease > stage 2
  • 10-year cardiovascular risk equivalent to 20% or greater using the QRisk2 calculator
  • Abnormality of laboratory blood tests considered clinically significant
  • Any other significant intercurrent condition/disease

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboPlacebo
TeaTeaBlack tea
Primary Outcome Measures
NameTimeMethod
Flow Mediated DilationBefore and 2 hours after test product intake

Flow mediated dilation (FMD) of the brachial artery was measured using vascular ultra sound and automated edge detection software:

* 1 minute baseline scan to measure the baseline diameter of artery

* 5 minutes of forearm occlusion at 250±30 mmHg, below the elbow (2-5 cm from antecubital crease)

* 4 minutes FMD scan, which started immediately after release of occlusion Percentage FMD was calculated as the maximum increase in diameter after cuff release relative to the baseline diameter

Secondary Outcome Measures
NameTimeMethod
Systolic Blood Pressure SupineBefore and 110 minutes after test product intake

Systolic blood pressure measured while lying down

Systolic Blood Pressure SittingBefore and 90 minutes after test product intake

Systolic blood pressure measured while sitting

Diastolic Blood Pressure SittingBefore and 90 minutes after test product intake

Diastolic blood pressure measured while sitting

Diastolic Blood Pressure SupineBefore and 110 minutes after test product intake

Diastolic blood pressure measured while lying down

Endothelium-independent Vasodilation2.5 hours after test product intake

Endothelium-independent dilation after glyceryl trinitrate defined as maximal percent increase in diameter

Trial Locations

Locations (1)

Dept Clinical Pharmacology/CRF, St Thomas Hospital

🇬🇧

London, United Kingdom

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