Effects of Black Tea on Cardiovascular Disease in the Mauritian Population

This study has been completed.
Sponsor:
Collaborators:
Mauritius Research Council
Cardiac Centre, Pamplemousses
London South Bank University
Information provided by:
University of Mauritius
ClinicalTrials.gov Identifier:
NCT00114907
First received: June 17, 2005
Last updated: April 5, 2007
Last verified: June 2005
  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: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Effects of Black Tea on Cardiovascular Disease in the Mauritian Population

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00114907     History of Changes
Other Study ID Numbers: TEA, MRC/RUN-0408
Study First Received: June 17, 2005
Last Updated: April 5, 2007
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:
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 01, 2014