Vascular Function Clinical Trial
— TOfficial title:
Flow Mediated Dilation in Response to Consumption of Black Tea Versus Artificial Tea, in Non-tea Drinking Hypertensive Subjects.
Verified date | November 2015 |
Source | Unilever R&D |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: National Health Service |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
United Kingdom | Dept Clinical Pharmacology/CRF, St Thomas Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Unilever R&D | King's College London |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Flow mediated dilation | Change in flow mediated dilation from baseline | before and 2 hours after test product intake | No |
Secondary | endothelium-independent vasodilation | Endothelium-independent dilation after glyceryl trinitrate | 2.5 hours after test product intake | No |
Secondary | Seated blood pressure | Seated blood pressure measurement (both systolic and diastolic) | 55 minutes before (baseline) and 90 minutes after and 175 minutes after test product intake | No |
Secondary | Supine blood pressure | Supine blood pressure measurement (both systolic and diastolic) | 35 minutes before (baseline) and 110 minutes after test product intake | No |
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