Flow Mediated Dilation in Response to Black Tea
- Conditions
- Vascular Function
- Interventions
- Other: PlaceboOther: 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
-
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
- 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
Group Intervention Description Placebo Placebo Placebo Tea Tea Black tea
- Primary Outcome Measures
Name Time Method Flow Mediated Dilation 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 Outcome Measures
Name Time Method Systolic Blood Pressure Supine Before and 110 minutes after test product intake Systolic blood pressure measured while lying down
Systolic Blood Pressure Sitting Before and 90 minutes after test product intake Systolic blood pressure measured while sitting
Diastolic Blood Pressure Sitting Before and 90 minutes after test product intake Diastolic blood pressure measured while sitting
Diastolic Blood Pressure Supine Before and 110 minutes after test product intake Diastolic blood pressure measured while lying down
Endothelium-independent Vasodilation 2.5 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