Effects of Black Tea on Cardiovascular Disease in the Mauritian Population

April 5, 2007 updated by: University of Mauritius
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mauritius
      • Reduit, Mauritius
        • University of Mauritius

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The study will assess the effect of tea consumption on the incidence of cardiovascular diseases

Secondary Outcome Measures

Outcome Measure
The effect of tea consumption will be evaluated on a number of markers of oxidative stress associated with cardiovascular disease

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mauritius

Collaborators

London South Bank University
Mauritius Research Council
Cardiac Centre, Pamplemousses

Investigators

  • Principal Investigator: Theeshan Bahorun, PhD, University of Mauritius

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion

June 1, 2005

Study Registration Dates

First Submitted

June 17, 2005

First Submitted That Met QC Criteria

June 17, 2005

First Posted (Estimate)

June 20, 2005

Study Record Updates

Last Update Posted (Estimate)

April 6, 2007

Last Update Submitted That Met QC Criteria

April 5, 2007

Last Verified

June 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEA
  • MRC/RUN-0408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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