Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Black Tea on Vascular Function (Heraclitus)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01945970
Recruitment Status : Completed
First Posted : September 19, 2013
Results First Posted : February 17, 2017
Last Update Posted : March 22, 2017
Sponsor:
Collaborator:
Sprim Advanced Life Sciences
Information provided by (Responsible Party):
Unilever R&D

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Vascular Function Other: Black tea extract Other: Positive control Other: Placebo Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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 Start Date : September 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Black tea extract
Spray dried aqueous extract of a representative batch of black tea
 Other: Black tea extract
Black tea extract
Active Comparator: Positive control
Spray dried aqueous extract of a batch of tea extract that has shown to improve FMD previously
 Other: Positive control
Positive control
Placebo Comparator: Placebo
Food grade colouring, artificial tea flavour and an amount of caffeine matched to the caffeine in the Black tea extract
 Other: Placebo
Placebo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Flow Mediated Dilation, Acute-upon-chronic, Black Tea [ Time Frame: From before consumption on day 1 to 2 hours post consumption on day 8. ]

    Flow mediated dilation (FMD) measurement included the following steps:

    • 1 minute base scan to measure the baseline diameter of artery (Resting stage)
    • 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
    • 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
    • When the artery had returned to baseline a second 1 minute scan was taken
    • 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
    • 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).


Secondary Outcome Measures :
  1. Flow Mediated Dilation, Acute, Black Tea [ Time Frame: From before consumption on day 1 to 2 hours post consumption on day 1 ]

    Flow mediated dilation (FMD) measurement included the following steps:

    • 1 minute base scan to measure the baseline diameter of artery (Resting stage)
    • 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
    • 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
    • When the artery had returned to baseline a second 1 minute scan was taken
    • 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
    • 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).

  2. Flow Mediated Dilation, Chronic, Black Tea [ Time Frame: From before consumption day 1 to before consumption day 8. ]

    Flow mediated dilation (FMD) measurement included the following steps:

    • 1 minute base scan to measure the baseline diameter of artery (Resting stage)
    • 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
    • 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
    • When the artery had returned to baseline a second 1 minute scan was taken
    • 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
    • 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).

  3. Flow Mediated Dilation, Acute-upon-chronic, Positive Control [ Time Frame: From before consumption on day 1 to 2 hours post consumption on day 8 ]

    Flow mediated dilation (FMD) measurement included the following steps:

    • 1 minute base scan to measure the baseline diameter of artery (Resting stage)
    • 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
    • 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
    • When the artery had returned to baseline a second 1 minute scan was taken
    • 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
    • 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).

  4. Flow Mediated Dilation, Acute, Positive Control [ Time Frame: From before consumption on day 1 to 2 hours post consumption on day 1 ]

    Flow mediated dilation (FMD) measurement included the following steps:

    • 1 minute base scan to measure the baseline diameter of artery (Resting stage)
    • 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
    • 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
    • When the artery had returned to baseline a second 1 minute scan was taken
    • 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
    • 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).

  5. Flow Mediated Dilation, Chronic, Positive Control [ Time Frame: From before consumption on day 1 to before consumption day 8 ]

    Flow mediated dilation (FMD) measurement included the following steps:

    • 1 minute base scan to measure the baseline diameter of artery (Resting stage)
    • 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
    • 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
    • When the artery had returned to baseline a second 1 minute scan was taken
    • 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
    • 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).


Other Outcome Measures:
  1. Systolic Blood Pressure, Black Tea [ Time Frame: From before consumption on day 1 to before consumption on day 8 ]
    Change in Systolic blood pressure

  2. Diastolic Blood Pressure Black Tea [ Time Frame: From before consumption on day 1 to before consumption day 8 ]
    Change in Diastolic blood pressure

  3. Systolic Blood Pressure, Positive Control [ Time Frame: From before consumption (baseline) day 1 to before consumption day 8 ]
    Change in systolic blood pressure

  4. Diastolic Blood Pressure, Positive Control [ Time Frame: From before consumption on day 1 to before consumption day 8 ]
    Change in Diastolic Blood pressure

  5. Endothelium Independent Dilation, Acute-upon-chronic, Black Tea [ Time Frame: From before consumption on day 1 to 2 hours post consumption on day 8 ]

    FMD measurement included the following steps:

    • 1 minute base scan to measure the baseline diameter of artery (Resting stage)
    • 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
    • 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
    • When the artery had returned to baseline a second 1 minute scan was taken
    • 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
    • 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).

  6. Endothelium Independent Dilation, Chronic, Black Tea [ Time Frame: From before consumption on day 1 to before consumption day 8 ]

    Flow mediated dilation (FMD) measurement included the following steps:

    • 1 minute base scan to measure the baseline diameter of artery (Resting stage)
    • 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
    • 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
    • When the artery had returned to baseline a second 1 minute scan was taken
    • 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
    • 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).

  7. Endothelium-Independent Dilation, Acute, Black Tea [ Time Frame: From before consumption on day 1 to 2 hours post consumption on day 1 ]

    Flow mediated dilation (FMD) measurement included the following steps:

    • 1 minute base scan to measure the baseline diameter of artery (Resting stage)
    • 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
    • 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
    • When the artery had returned to baseline a second 1 minute scan was taken
    • 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
    • 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).

  8. Endothelium Independent Dilation, Acute-upon-chronic, Positive Control [ Time Frame: From before consumption on day 1 to 2 hours post consumption on day 8 ]

    Flow mediated dilation (FMD) measurement included the following steps:

    • 1 minute base scan to measure the baseline diameter of artery (Resting stage)
    • 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
    • 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
    • When the artery had returned to baseline a second 1 minute scan was taken
    • 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
    • 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).

  9. Endothelium Independent Dilation, Chronic, Positive Control [ Time Frame: From before consumption on day 1 to before consumption day 8 ]

    Flow mediated dilation (FMD) measurement included the following steps:

    • 1 minute base scan to measure the baseline diameter of artery (Resting stage)
    • 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
    • 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
    • When the artery had returned to baseline a second 1 minute scan was taken
    • 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
    • 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).

  10. Endothelium Independent Dilation, Acute, Positive Control [ Time Frame: From before consumption on day 1 to 2 hours post consumption on day 1 ]

    Flow mediated dilation (FMD) measurement included the following steps:

    • 1 minute base scan to measure the baseline diameter of artery (Resting stage)
    • 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
    • 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
    • When the artery had returned to baseline a second 1 minute scan was taken
    • 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
    • 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945970


Locations
Layout table for location information
Italy
Azienda Ospedaliero-Universitaria Pisana, Centro di Farmacologia Clinicaper la Sperimentazione dei Farmaci
Pisa, Italy
Sponsors and Collaborators
Unilever R&D
Sprim Advanced Life Sciences
Investigators
Layout table for investigator information
Principal Investigator: Lorenzo Ghiadoni, MD University of Pisa, Internal medicine
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01945970    
Other Study ID Numbers: REF-BEV-1134
First Posted: September 19, 2013    Key Record Dates
Results First Posted: February 17, 2017
Last Update Posted: March 22, 2017
Last Verified: February 2017
Keywords provided by Unilever R&D:
Vascular function
Flow mediated dilation
Tea