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Completed

NCT Number: NCT00114907

Effects of Black Tea on Cardiovascular Disease in the Mauritian Population

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.

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Key information

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Mauritius

Réduit, Mauritius

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Consumption of black tea

Behavioral

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Mauritius

Other

Collaborators

  • Cardiac Centre, Pamplemousses
  • London South Bank University
  • Mauritius Research Council

Registry information

Important dates

Study start
2005
Study completion
2005
First posted
Jun 20, 2005
Registry last updated
Apr 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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