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.

Condition	Intervention
Cardiac Disease	Behavior: Consumption of black tea

Further Study Details: 

Primary Outcomes: The study will assess the effect of tea consumption on the incidence of cardiovascular diseases
Secondary Outcomes: The effect of tea consumption will be evaluated on a number of markers of oxidative stress associated with cardiovascular disease
Expected Total Enrollment:  270

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.

Ages Eligible for Study:  25 Years   -   70 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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

Mauritius
      University of Mauritius, Reduit,  Mauritius

Study chairs or principal investigators

Theeshan Bahorun, PhD,  Principal Investigator

Study ID Numbers:  TEA; MRC/RUN-0408
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 17, 2005
ClinicalTrials.gov Identifier:  NCT00114907
Health Authority: Mauritius: Ministry of Health and Quality of Life
ClinicalTrials.gov processed this record on 2005-07-05