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Effects of Black Tea on Cardiovascular Disease in the Mauritian Population

This study has been completed.
Sponsor:
Collaborators:
Mauritius Research Council
Cardiac Centre, Pamplemousses
London South Bank University
Information provided by:
University of Mauritius
ClinicalTrials.gov Identifier:
NCT00114907
First received: June 17, 2005
Last updated: April 5, 2007
Last verified: June 2005

June 17, 2005
April 5, 2007
June 2005
Not Provided
The study will assess the effect of tea consumption on the incidence of cardiovascular diseases
Same as current
Complete list of historical versions of study NCT00114907 on ClinicalTrials.gov Archive Site
The effect of tea consumption will be evaluated on a number of markers of oxidative stress associated with cardiovascular disease
Same as current
Not Provided
Not Provided
 
Effects of Black Tea on Cardiovascular Disease in the Mauritian Population
Effects of Black Tea on Cardiovascular Disease in the Mauritian Population

It is proposed to investigate the association between consumption of black tea and various selective fasting blood serum and urine biomarkers in a Mauritian population with ischaemic heart diseases. This study, the first of its kind, will provide clinical data on the potential prophylactic propensities of Mauritian black tea against cardiovascular disease, which remains one of the major health threats to the Mauritian population.

OBJECTIVES

Our broad objectives will be to:

  • Survey and recruit patients with ischaemic heart diseases in a randomized sample representative of the Mauritian population (ethnicity, gender, age, social and economical status) and record their medical history,
  • Collect fasting blood serum and urine at baseline and after supplement of control volume of tea infusion and water from study group and control group respectively,
  • Optimize techniques to determine levels of specific biomarkers from above body fluid samples,
  • Investigate existing correlation between tea consumption and risk of cardiovascular diseases in Mauritian population

Our specific objectives will be to:

  • Select a randomised group of the Mauritian population, with ischaemic heart disease, who has been referred to the Cardiac Centre, Pamplemousses for Angiography and a group of people showing no risk of cardiovascular diseases
  • Inform the people about the motives of the study and seek consent from those willing to participate in the study,
  • Evaluate the levels of biomarkers of oxidative stress (total cholesterol, LDL, HDL, triglycerides, homocysteine, atrial natriuretic peptides, brain natriuretic peptides, 8-hydroxydeoxyguanosine, isoprostanes, hydroxyeicosatetraenoic acid, products of protein damage, uric acid and glycosylated haemoglobin) from 8-10 hr fasting blood serum and urine at baseline from all participants
  • Supply the study group with a control volume of tea infusion and the control group with the same amount of water for a defined period of time followed by a two week wash out period with water.
  • Study biomarkers as above from 8-10 hr fasting blood serum and urine in two week intervals during the supplement regime
  • Investigate the existing correlation between tea consumption and levels of biomarkers of cardiovascular diseases in a Mauritian sample population.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Cardiac Disease
Behavioral: Consumption of black tea
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
June 2005
Not Provided

Inclusion Criteria:

  • 25-70 years
  • Non smokers
  • Left ventricular ejection fraction>40%

Exclusion Criteria:

  • Alcohol consumption > 4 standard drinks/day
  • Postmenopausal women receiving hormone replacement therapy
Both
25 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Mauritius
 
NCT00114907
TEA, MRC/RUN-0408
Not Provided
Not Provided
University of Mauritius
  • Mauritius Research Council
  • Cardiac Centre, Pamplemousses
  • London South Bank University
Principal Investigator: Theeshan Bahorun, PhD University of Mauritius
University of Mauritius
June 2005

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