Status:
COMPLETED
Flow Mediated Dilation in Response to Black Tea
Lead Sponsor:
Unilever R&D
Collaborating Sponsors:
King's College London
Conditions:
Vascular Function
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02273323
Start Date
October 1 2014
End Date
October 1 2015
Last Update
February 15 2017
Active Locations (1)
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1
Dept Clinical Pharmacology/CRF, St Thomas Hospital
London, United Kingdom, SE1 7EH