Effects of Black Tea on Cardiovascular Disease in the Mauritian Population - Full Text View

Sponsor:	University of Mauritius
Collaborators:	Mauritius Research Council Cardiac Centre, Pamplemousses London South Bank University
Information provided by:	University of Mauritius
ClinicalTrials.gov Identifier:	NCT00114907

Purpose

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.

Condition	Intervention
Cardiac Disease	Behavioral: Consumption of black tea

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Bio-availability Study
Official Title:	Effects of Black Tea on Cardiovascular Disease in the Mauritian Population

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases

U.S. FDA Resources

Further study details as provided by University of Mauritius:

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

Estimated Enrollment:	270
Study Start Date:	June 2005
Estimated Study Completion Date:	June 2005

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.

Eligibility

Ages Eligible for Study:	25 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114907

Locations

Mauritius
University of Mauritius
Reduit, Mauritius

Sponsors and Collaborators

University of Mauritius

Mauritius Research Council

Cardiac Centre, Pamplemousses

London South Bank University

Investigators

Principal Investigator:

Theeshan Bahorun, PhD

University of Mauritius

More Information

No publications provided

Study ID Numbers:	TEA, MRC/RUN-0408
Study First Received:	June 17, 2005
Last Updated:	April 5, 2007
ClinicalTrials.gov Identifier:	NCT00114907 History of Changes
Health Authority:	Mauritius: Ministry of Health and Quality of Life

Keywords provided by University of Mauritius:

Tea
Oxidative stress markers
cardiovascular disease

polyphenolics
double blind
Ischaemic cardiac disease

Additional relevant MeSH terms:

Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010