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

September 8, 2013
December 3, 2013
September 2013
November 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01945970 on ClinicalTrials.gov Archive Site
  • 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
Same as current
  • 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
Same as current
 
Effect of Black Tea on Vascular Function
Randomized Double Blind Placebo Controlled Crossover Study to Assess the Effect of Black Tea on Flow-Mediated Dilation in Healthy, Non-tea Drinking Males

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Vascular Function
  • Other: Black tea extract
    Black tea extract
  • Other: Positive control
    Positive control
  • Other: Placebo
    Placebo
  • Experimental: Black tea extract
    Spray dried aqueous extract of a representative batch of black tea
    Intervention: Other: Black tea extract
  • Active Comparator: Positive control
    Spray dried aqueous extract of a batch of tea extract that has shown to improve FMD previously
    Intervention: Other: 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
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2013
November 2013   (final data collection date for primary outcome measure)

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).
Male
40 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01945970
REF-BEV-1134
No
Unilever R&D
Unilever R&D
Sprim Advanced Life Sciences
Principal Investigator: Lorenzo Ghiadoni, MD University of Pisa, Internal medicine
Unilever R&D
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP