Clinical trial NCT00114907: Effects of Black Tea on Cardiovascular Disease in the Mauritian Population
Official title: Effects of Black Tea on Cardiovascular Disease in the Mauritian Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Disease
Keywords: Tea
Oxidative stress markers
cardiovascular disease
polyphenolics
double blind
Ischaemic cardiac disease
Lead sponsor: University of Mauritius
Sponsor class: OTHER
Collaborators: name: Mauritius Research Council
name: Cardiac Centre, Pamplemousses
name: London South Bank University
First posted: 2005-06-20
Enrollment: 270
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: The study will assess the effect of tea consumption on the incidence of cardiovascular diseases
Secondary outcomes:
measure: The effect of tea consumption will be evaluated on a number of markers of oxidative stress associated with cardiovascular disease
Other outcomes:
Locations:
city: Reduit
country: Mauritius
facility: University of Mauritius
Study officials:
affiliation: University of Mauritius
name: Theeshan Bahorun, PhD
role: PRINCIPAL_INVESTIGATOR
References: