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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02273323
Other study ID # REF-BEV-1376
Secondary ID
Status Completed
Phase N/A
First received October 21, 2014
Last updated November 17, 2015
Start date October 2014
Est. completion date October 2015

Study information

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

Clinical Trial 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.


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 information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Other:
Tea
Single dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar.
Placebo
Placebo: tea flavour, colouring and sugar

Locations

Country Name City State
United Kingdom Dept Clinical Pharmacology/CRF, St Thomas Hospital London

Sponsors (2)

Lead Sponsor Collaborator
Unilever R&D King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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