Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 3, 2013
Last verified: December 2013
  Purpose

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 Intervention
Vascular Function
Other: Black tea extract
Other: Positive control
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Unilever R&D:

Primary Outcome Measures:
  • Change in flow mediated dilation from baseline on day 1 to post consumption on day 8. [ Time Frame: Day 1 and day 8 ] [ Designated as safety issue: No ]
    The 'acute upon chronic effect' of black tea on flow mediated dilation.


Secondary Outcome Measures:
  • Change in flow mediated dilation from baseline on day 1 to post consumption on day 1. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The 'acute effect' of black tea extract on flow mediated dilation.

  • Change in flow mediated dilation from post consumption on day 1 to post consumption on day 8. [ Time Frame: Day 1 and day 8 ] [ Designated as safety issue: No ]
    The 'chronic effect' of black tea on flow mediated dilation.

  • Change in flow mediated dilation from baseline on day 1 to post consumption on day 8. [ Time Frame: Day 1 and day 8 ] [ Designated as safety issue: No ]
    The 'acute upon chronic effect' of positive control on flow mediated dilation.

  • Change in flow mediated dilation from baseline on day 1 to post consumption on day 1. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The 'acute effect' of positive control on flow mediated dilation.

  • Change in flow mediated dilation from post consumption on day 1 to post consumption day 8. [ Time Frame: Day 1 and day 8 ] [ Designated as safety issue: No ]
    The 'chronic effect' of positive control tea extract on flow mediated dilation


Other Outcome Measures:
  • The effect on changes in blood pressure (systolic and diastolic will be analysed). [ Time Frame: Day 1 and day 8 ] [ Designated as safety issue: No ]
    Blood pressure will be measured before each FMD measurements.

  • The effects on changes in endothelium-independent dilation (after glyceryl trinitrate). [ Time Frame: Day 1 and day 8 ] [ Designated as safety issue: No ]
    Calculated as for endothelium dependent flow mediated dilation


Enrollment: 30
Study Start Date: September 2013
Study Completion Date: December 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   40 Years to 65 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01945970

Locations
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
Principal Investigator: Lorenzo Ghiadoni, MD University of Pisa, Internal medicine
  More Information

No publications provided

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
Last Updated: December 3, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by Unilever R&D:
Vascular function
Flow mediated dilation
Tea

ClinicalTrials.gov processed this record on November 20, 2014