Effect of Black Tea on Vascular Function

Vascular Function Clinical Trial

— Heraclitus  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945970
• Other study ID #: REF-BEV-1134
• Status: Completed
• Phase: N/A
• First received: September 8, 2013
• Last updated: December 3, 2013
• Start date: September 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Vascular Function

Intervention

Other:
• Black tea extract
Black tea extract
• Positive control
Positive control
• Placebo
Placebo

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria Pisana, Centro di Farmacologia Clinicaper la Sperimentazione dei Farmaci	Pisa

Sponsors (2)

Lead Sponsor	Collaborator
Unilever R&D	Sprim Advanced Life Sciences

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The effect on changes in blood pressure (systolic and diastolic will be analysed).	Blood pressure will be measured before each FMD measurements.	Day 1 and day 8	No
Other	The effects on changes in endothelium-independent dilation (after glyceryl trinitrate).	Calculated as for endothelium dependent flow mediated dilation	Day 1 and day 8	No
Primary	Change in flow mediated dilation from baseline on day 1 to post consumption on day 8.	The 'acute upon chronic effect' of black tea on flow mediated dilation.	Day 1 and day 8	No
Secondary	Change in flow mediated dilation from baseline on day 1 to post consumption on day 1.	The 'acute effect' of black tea extract on flow mediated dilation.	Day 1	No
Secondary	Change in flow mediated dilation from post consumption on day 1 to post consumption on day 8.	The 'chronic effect' of black tea on flow mediated dilation.	Day 1 and day 8	No
Secondary	Change in flow mediated dilation from baseline on day 1 to post consumption on day 8.	The 'acute upon chronic effect' of positive control on flow mediated dilation.	Day 1 and day 8	No
Secondary	Change in flow mediated dilation from baseline on day 1 to post consumption on day 1.	The 'acute effect' of positive control on flow mediated dilation.	Day 1	No
Secondary	Change in flow mediated dilation from post consumption on day 1 to post consumption day 8.	The 'chronic effect' of positive control tea extract on flow mediated dilation	Day 1 and day 8	No