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
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 April 17, 2014