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Effect of Black Tea on Vascular Function (Heraclitus)

This study has been completed.
Sponsor:
Collaborator:
Sprim Advanced Life Sciences
Information provided by (Responsible Party):
Unilever R&D
ClinicalTrials.gov Identifier:
NCT01945970
First received: September 8, 2013
Last updated: December 23, 2016
Last verified: December 2016
Results First Received: December 23, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Vascular Function
Interventions: Other: Black tea extract
Other: Positive control
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
30 suitable subjects recruited from database

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
30 subjects randomised

Reporting Groups
  Description
Black Tea - Positive Control - Placebo

Subjects treated in the order Black tea - wash out- Positive control - wash out - Placebo.

Treatments each lasted one week and were separated by a one week washout.

Black Tea - Placebo - Positive Control

Subjects treated in the order Black tea - wash out- Placebo control - wash out - Positive control.

Treatments each lasted one week and were separated by a one week washout.

Positive Control - Black Tea - Placebo

Subjects treated in the order Positive control - wash out - Black tea - wash out - Placebo.

Treatments each lasted one week and were separated by a one week washout.

Positive Control - Placebo - Black Tea

Subjects treated in the order Positive control - wash out - Placebo - wash out - Black tea.

Treatments each lasted one week and were separated by a one week washout.

Placebo- Positive Control - Black Tea

Subjects treated in the order Placebo - wash out - Positive control - wash out- Black tea.

Treatments each lasted one week and were separated by a one week washout.

Placebo - Black Tea - Positive Control

Subjects treated in the order Placebo - wash out - Black tea - wash out- Positive control.

Treatments each lasted one week and were separated by a one week washout.


Participant Flow:   Overall Study
    Black Tea - Positive Control - Placebo   Black Tea - Placebo - Positive Control   Positive Control - Black Tea - Placebo   Positive Control - Placebo - Black Tea   Placebo- Positive Control - Black Tea   Placebo - Black Tea - Positive Control
STARTED   5   5   5   5   5   5 
COMPLETED   5   5   5   5   5   5 
NOT COMPLETED   0   0   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Cross over study where all subjects recieved all treatments

Reporting Groups
  Description
Study Subjects All six treatment orders combined

Baseline Measures
   Study Subjects 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Years]
Median (Full Range)
 43 
 (30 to 61) 
Gender 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      30 100.0% 
Region of Enrollment 
[Units: Participants]
 
Italy   30 
Body mass index 
[Units: Kg/m2]
Mean (Standard Deviation)
 25.0  (2.4) 
Systolic blood pressure 
[Units: mmHg]
Mean (Standard Deviation)
 118  (12) 
Diastolic blood pressure 
[Units: mmHg]
Mean (Standard Deviation)
 74  (8) 


  Outcome Measures
  Show All Outcome Measures

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

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

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

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

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

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

7.  Other Pre-specified:   Systolic Blood Pressure, Black Tea   [ Time Frame: From before consumption on day 1 to before consumption on day 8 ]

8.  Other Pre-specified:   Diastolic Blood Pressure Black Tea   [ Time Frame: From before consumption on day 1 to before consumption day 8 ]

9.  Other Pre-specified:   Systolic Blood Pressure, Positive Control   [ Time Frame: From before consumption (baseline) day 1 to before consumption day 8 ]

10.  Other Pre-specified:   Diastolic Blood Pressure, Positive Control   [ Time Frame: From before consumption on day 1 to before consumption day 8 ]

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

12.  Other Pre-specified:   Endothelium Independent Dilation, Chronic, Black Tea   [ Time Frame: From before consumption on day 1 to before consumption day 8 ]

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

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

15.  Other Pre-specified:   Endothelium Independent Dilation, Chronic, Positive Control   [ Time Frame: From before consumption on day 1 to before consumption day 8 ]

16.  Other Pre-specified:   Endothelium Independent Dilation, Acute, Positive Control   [ Time Frame: From before consumption on day 1 to 2 hours post consumption on day 1 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Theo Mulder
Organization: Unilever R&D Research Vlaardingen
phone: +31 10 460 8315
e-mail: theo.mulder@gmail.com



Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01945970     History of Changes
Other Study ID Numbers: REF-BEV-1134
Study First Received: September 8, 2013
Results First Received: December 23, 2016
Last Updated: December 23, 2016