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Effects of Black Tea on Cardiovascular Disease in the Mauritian Population

U

University of Mauritius

Status

Completed

Conditions

Cardiac Disease

Treatments

Behavioral: Consumption of black tea

Study type

Interventional

Funder types

Other

Identifiers

NCT00114907
TEA
MRC/RUN-0408

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

25 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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