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Effects of Black Tea on Cardiovascular Disease in the Mauritian Population

NCT ID: NCT00114907

Last Updated: 2007-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2005-06-30

Brief Summary

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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

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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.

Conditions

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Cardiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Consumption of black tea

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mauritius Research Council

OTHER

Sponsor Role collaborator

Cardiac Centre, Pamplemousses

OTHER

Sponsor Role collaborator

London South Bank University

OTHER

Sponsor Role collaborator

University of Mauritius

OTHER

Sponsor Role lead

Principal Investigators

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Theeshan Bahorun, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Mauritius

Locations

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University of Mauritius

Réduit, , Mauritius

Site Status

Countries

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Mauritius

Other Identifiers

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MRC/RUN-0408

Identifier Type: -

Identifier Source: secondary_id

TEA

Identifier Type: -

Identifier Source: org_study_id