Clinical trial NCT01945970: Effect of Black Tea on Vascular Function
Official title: Randomized Double Blind Placebo Controlled Crossover Study to Assess the Effect of Black Tea on Flow-Mediated Dilation in Healthy, Non-tea Drinking Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Function
Keywords: Vascular function
Flow mediated dilation
Tea
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
Collaborators: name: Sprim Advanced Life Sciences
First posted: 2013-09-19
Enrollment: 30
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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 (FMD).

Detailed description: The current study tests a specific Black tea extract against a placebo in population that has previously show to be sensitive to the effect of black tea on Flow Mediated dilation. A tea extract that has previously been shown to improve FMD is included as the positive control.

Eligibility criteria: Inclusion Criteria:

* Apparently healthy male volunteers with no history of cardiovascular disease
* Having body mass index (BMI) of between 18.0 and 30.0 kg/m2 (inclusive)
* Non-smokers (\> 2 years)
* Non-tea drinkers (less or equal 1 cup/week)
* Limited alcohol intake (less or equal 21 units/week)
* Systolic blood pressure less or equal 160 mmHg and/or diastolic blood pressure less or equal 100 mmHg at screening
* Brachial artery can be imaged using ultrasound and at screening FMD value is within the expected range as judged by the PI
* Judged to be in good health on the basis of medical history, physical examination and routine laboratory tests (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, glucose, highly sensitive C-reactive protein).

Primary outcomes:
measure: Flow Mediated Dilation, Acute-upon-chronic, Black Tea
timeFrame: From before consumption on day 1 to 2 hours post consumption on day 8.
Secondary outcomes:
measure: Flow Mediated Dilation, Acute, Black Tea
timeFrame: From before consumption on day 1 to 2 hours post consumption on day 1
measure: Flow Mediated Dilation, Chronic, Black Tea
timeFrame: From before consumption day 1 to before consumption day 8.
measure: Flow Mediated Dilation, Acute-upon-chronic, Positive Control
timeFrame: From before consumption on day 1 to 2 hours post consumption on day 8
measure: Flow Mediated Dilation, Acute, Positive Control
timeFrame: From before consumption on day 1 to 2 hours post consumption on day 1
measure: Flow Mediated Dilation, Chronic, Positive Control
timeFrame: From before consumption on day 1 to before consumption day 8
Other outcomes:
measure: Systolic Blood Pressure, Black Tea
timeFrame: From before consumption on day 1 to before consumption on day 8
measure: Diastolic Blood Pressure Black Tea
timeFrame: From before consumption on day 1 to before consumption day 8
measure: Systolic Blood Pressure, Positive Control
timeFrame: From before consumption (baseline) day 1 to before consumption day 8
measure: Diastolic Blood Pressure, Positive Control
timeFrame: From before consumption on day 1 to before consumption day 8
measure: Endothelium Independent Dilation, Acute-upon-chronic, Black Tea
timeFrame: From before consumption on day 1 to 2 hours post consumption on day 8
measure: Endothelium Independent Dilation, Chronic, Black Tea
timeFrame: From before consumption on day 1 to before consumption day 8
measure: Endothelium-Independent Dilation, Acute, Black Tea
timeFrame: From before consumption on day 1 to 2 hours post consumption on day 1
measure: Endothelium Independent Dilation, Acute-upon-chronic, Positive Control
timeFrame: From before consumption on day 1 to 2 hours post consumption on day 8
measure: Endothelium Independent Dilation, Chronic, Positive Control
timeFrame: From before consumption on day 1 to before consumption day 8
measure: Endothelium Independent Dilation, Acute, Positive Control
timeFrame: From before consumption on day 1 to 2 hours post consumption on day 1
Locations:
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana, Centro di Farmacologia Clinicaper la Sperimentazione dei Farmaci
Study officials:
affiliation: University of Pisa, Internal medicine
name: Lorenzo Ghiadoni, MD
role: PRINCIPAL_INVESTIGATOR
References: