Effects of Black Tea on Cardiovascular Disease in the Mauritian Population

Cardiac Disease Clinical Trial

Official title:

Effects of Black Tea on Cardiovascular Disease in the Mauritian Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00114907
• Other study ID #: TEA
• Secondary ID: MRC/RUN-0408
• Status: Completed
• Phase: N/A
• First received: June 17, 2005
• Last updated: April 5, 2007
• Start date: June 2005
• Est. completion date: June 2005

Study information

• Verified date: June 2005
• Source: University of Mauritius
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mauritius: Ministry of Health and Quality of Life
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiac Disease
• Cardiovascular Diseases
• Heart Diseases

Intervention

Behavioral:
• Consumption of black tea

Locations

Country	Name	City	State
Mauritius	University of Mauritius	Reduit

Sponsors (4)

Lead Sponsor	Collaborator
University of Mauritius	Cardiac Centre, Pamplemousses, London South Bank University, Mauritius Research Council

Country where clinical trial is conducted

Mauritius, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The study will assess the effect of tea consumption on the incidence of cardiovascular diseases
Secondary	The effect of tea consumption will be evaluated on a number of markers of oxidative stress associated with cardiovascular disease