Effects of Black Tea on Cardiovascular Disease in the Mauritian Population

This study has been completed.

Sponsor:

Collaborators:

Mauritius Research Council

Cardiac Centre, Pamplemousses

London South Bank University

Information provided by:

University of Mauritius

ClinicalTrials.gov Identifier:

NCT00114907

First received: June 17, 2005

Last updated: April 5, 2007

Last verified: June 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

June 17, 2005

Last Updated Date

April 5, 2007

Start Date ^ICMJE

June 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00114907 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effects of Black Tea on Cardiovascular Disease in the Mauritian Population

Official Title ^ICMJE

Effects of Black Tea on Cardiovascular Disease in the Mauritian Population

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Cardiac Disease

Intervention ^ICMJE

Behavioral: Consumption of black tea

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

270

Completion Date

June 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

25 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Mauritius

Administrative Information

NCT Number ^ICMJE

NCT00114907

Other Study ID Numbers ^ICMJE

TEA, MRC/RUN-0408

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Mauritius

Collaborators ^ICMJE

Mauritius Research Council
Cardiac Centre, Pamplemousses
London South Bank University

Investigators ^ICMJE

Principal Investigator:

Theeshan Bahorun, PhD

University of Mauritius

Information Provided By

University of Mauritius

Verification Date

June 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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