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OpenTrials
Completed

NCT Number: NCT02273323

Flow Mediated Dilation in Response to Black Tea

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept Clinical Pharmacology/CRF, St Thomas Hospital

London, SE1 7EH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tea

Other

Single dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar.

Placebo

Other

Placebo: tea flavour, colouring and sugar

Primary outcomes

  1. Flow Mediated Dilation

    Time frame: Before 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 outcomes

  1. Endothelium-independent Vasodilation

    Time frame: 2.5 hours after test product intake

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

  2. Systolic Blood Pressure Supine

    Time frame: Before and 110 minutes after test product intake

    Systolic blood pressure measured while lying down

  3. Diastolic Blood Pressure Supine

    Time frame: Before and 110 minutes after test product intake

    Diastolic blood pressure measured while lying down

  4. Systolic Blood Pressure Sitting

    Time frame: Before and 90 minutes after test product intake

    Systolic blood pressure measured while sitting

  5. Diastolic Blood Pressure Sitting

    Time frame: Before and 90 minutes after test product intake

    Diastolic blood pressure measured while sitting

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Collaborators

  • King's College London

Registry information

Official study title

Flow Mediated Dilation in Response to Consumption of Black Tea Versus Artificial Tea, in Non-tea Drinking Hypertensive Subjects.

Acronym: T

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 23, 2014
Registry last updated
Feb 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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