Viewing Study NCT00114907



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Last Modification Date: 2024-10-26 @ 9:12 AM
Study NCT ID: NCT00114907
Status: COMPLETED
Last Update Posted: 2007-04-06
First Post: 2005-06-17

Brief Title: Effects of Black Tea on Cardiovascular Disease in the Mauritian Population
Sponsor: University of Mauritius
Organization: University of Mauritius

Study Overview

Official Title: Effects of Black Tea on Cardiovascular Disease in the Mauritian Population
Status: COMPLETED
Status Verified Date: 2005-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
MRCRUN-0408 None None None