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Efficacy of Brooke Bond Black Tea Extract on Flow Mediated Dilation in Indian Males

This study has been completed.
Sponsor:
Collaborators:
Lotus Labs Pvt. Ltd, Bangalore, India
Clumax Diagnostics, Bangalore, India
Quipu S.r.l, Pisa, Italy
Information provided by (Responsible Party):
Unilever R&D
ClinicalTrials.gov Identifier:
NCT01561300
First received: March 20, 2012
Last updated: February 16, 2017
Last verified: February 2017
Results First Received: December 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Other
Condition: Healthy
Interventions: Other: Nutrition intervention study with a black tea extract
Other: Nutrition intervention study with a control

  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
Forty five subjects were invited for screening. Two subjects did not come for the screening, three subjects were not willing to participate and three subjects did not fulfil the inclusion criteria. Of the 37 subjects that fulfilled all inclusion an exclusion criteria 30 were invited to participate.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Thirty subjects meeting all criteria were randomised over the two arms

Reporting Groups
  Description
Control, Then Washout, Then Tea Subjects first received Control for one week with Flow Mediated Dilation (FMD) measurements on day 1 and day 8. After a washout of one week (day 8-15) they received Tea for one week with FMD measurements at day 16 and day 22. All FMD measurements were done in a fasted state just before test product intake and exactly 2 hours after test product intake.
Tea, Then Wash Out, Then Control Subjects first received Tea for one week with with Flow Mediated Dilation (FMD) measurements on day 1 and day 8. After a washout of one week (day 8-15) they received Control for one week with FMD measurements at day 16 and day 22. All FMD measurements were done in a fasted state just before test product intake and exactly 2 hours after test product intake.

Participant Flow for 4 periods

Period 1:   Run in on Placebo
    Control, Then Washout, Then Tea   Tea, Then Wash Out, Then Control
STARTED   15   15 
COMPLETED   14   15 
NOT COMPLETED   1   0 
Adverse Event                1                0 

Period 2:   First Intervention
    Control, Then Washout, Then Tea   Tea, Then Wash Out, Then Control
STARTED   14   15 
COMPLETED   14   15 
NOT COMPLETED   0   0 

Period 3:   Washout on Placebo
    Control, Then Washout, Then Tea   Tea, Then Wash Out, Then Control
STARTED   14   15 
COMPLETED   14   15 
NOT COMPLETED   0   0 

Period 4:   Second Intervention
    Control, Then Washout, Then Tea   Tea, Then Wash Out, Then Control
STARTED   14   15 
COMPLETED   14   15 
NOT COMPLETED   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.
No text entered.

Reporting Groups
  Description
Study Population All participants who were randomised

Baseline Measures
   Study Population 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Years]
Median (Full Range)
 
Age   36 
 (30 to 46) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      30 100.0% 
Region of Enrollment 
[Units: Participants]
 
India   30 
Body Mass Index 
[Units: Kg/m^2]
Median (Full Range)
 23.2 
 (18.5 to 26.4) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   'Acute-upon-chronic Effect' of Tea vs Control   [ Time Frame: Baseline day 1 to 2 hours post consumption on day 8. ]

2.  Secondary:   Acute Effect of Tea vs Control   [ Time Frame: From baseline on day 1 to 2 hours post consumption on day 1 ]

3.  Secondary:   Chronic Effect of Tea vs Control   [ Time Frame: From baseline at day 1 to baseline on day 8 ]


  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 Vlaardingen
phone: +31 10 460 8315
e-mail: theo.mulder@unilever.com



Responsible Party: Unilever R&D
ClinicalTrials.gov Identifier: NCT01561300     History of Changes
Other Study ID Numbers: FDS-BEV-0284
Study First Received: March 20, 2012
Results First Received: December 21, 2016
Last Updated: February 16, 2017