Clinical Trials Directory

Trials / Completed

CompletedNCT00114907

Effects of Black Tea on Cardiovascular Disease in the Mauritian Population

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
270 (planned)
Sponsor
University of Mauritius · Academic / Other
Sex
All
Age
25 Years – 70 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALConsumption of black tea

Timeline

Start date
2005-06-01
Completion
2005-06-01
First posted
2005-06-20
Last updated
2007-04-06

Locations

1 site across 1 country: Mauritius

Source: ClinicalTrials.gov record NCT00114907. Inclusion in this directory is not an endorsement.