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Effects of Black Tea on Cardiovascular Disease in the Mauritian Population

Primary Purpose

Cardiac Disease

Status
Completed
Phase
Not Applicable
Locations
Mauritius
Study Type
Interventional
Intervention
Consumption of black tea
Sponsored by
University of Mauritius
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Disease focused on measuring Tea, Oxidative stress markers, cardiovascular disease, polyphenolics, double blind, Ischaemic cardiac disease

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Mauritius

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 17, 2005
Last Updated
April 5, 2007
Sponsor
University of Mauritius
Collaborators
Mauritius Research Council, Cardiac Centre, Pamplemousses, London South Bank University
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1. Study Identification

Unique Protocol Identification Number
NCT00114907
Brief Title
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

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Mauritius
Collaborators
Mauritius Research Council, Cardiac Centre, Pamplemousses, London South Bank University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease
Keywords
Tea, Oxidative stress markers, cardiovascular disease, polyphenolics, double blind, Ischaemic cardiac disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
270 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Consumption of black tea
Primary Outcome Measure Information:
Title
The study will assess the effect of tea consumption on the incidence of cardiovascular diseases
Secondary Outcome Measure Information:
Title
The effect of tea consumption will be evaluated on a number of markers of oxidative stress associated with cardiovascular disease

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theeshan Bahorun, PhD
Organizational Affiliation
University of Mauritius
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mauritius
City
Reduit
Country
Mauritius

12. IPD Sharing Statement

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Effects of Black Tea on Cardiovascular Disease in the Mauritian Population

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