- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00114907
Effects of Black Tea on Cardiovascular Disease in the Mauritian Population
April 5, 2007 updated by: University of Mauritius
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
270
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Reduit, Mauritius
- University of Mauritius
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
The study will assess the effect of tea consumption on the incidence of cardiovascular diseases
|
Secondary Outcome Measures
Outcome Measure |
---|
The effect of tea consumption will be evaluated on a number of markers of oxidative stress associated with cardiovascular disease
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Theeshan Bahorun, PhD, University of Mauritius
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Study Completion
June 1, 2005
Study Registration Dates
First Submitted
June 17, 2005
First Submitted That Met QC Criteria
June 17, 2005
First Posted (Estimate)
June 20, 2005
Study Record Updates
Last Update Posted (Estimate)
April 6, 2007
Last Update Submitted That Met QC Criteria
April 5, 2007
Last Verified
June 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TEA
- MRC/RUN-0408
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiac Disease
-
University of British ColumbiaRecruitingSurgery | Cardiac Event | Cardiac Disease | Cardiac Complication | Cardiac Valve Disease | Surgery-ComplicationsCanada
-
Istituto Auxologico ItalianoRecruitingCardiovascular Diseases | Cardiomyopathies | Ischemic Heart Disease | Sudden Cardiac Death Due to Cardiac ArrhythmiaItaly
-
Ostfold University CollegeNot yet recruitingCardiac Arrest | Cardiac Arrhythmia | Cardiac Disease | Cardiac Death
-
Johns Hopkins UniversityNational Human Genome Research Institute (NHGRI)Enrolling by invitationGenetic Counseling | Inherited Cardiac DiseaseUnited States
-
Centro Medico TeknonRecruitingMyocardial Infarction | Ischemic Heart Disease | Ventricular Tachycardia | Magnetic Resonance Imaging | Ventricular Arrythmia | Sudden Cardiac Death | Sudden Cardiac Death Due to Cardiac ArrhythmiaSpain
-
Children's Healthcare of AtlantaTerminated
-
Beijing Chao Yang HospitalBeijing Boren Hospital; Beijing Chuiyangliu HospitalNot yet recruitingM-protein Related Cardiac Disease
-
Maastricht University Medical CenterActive, not recruitingHeart Diseases | Cardiac Conduction DefectNetherlands
-
US Department of Veterans AffairsCompleted
-
Vanderbilt University Medical CenterCompletedCardiac DiseasesUnited States
Clinical Trials on Consumption of black tea
-
University of ArizonaUnited States Department of DefenseCompletedLung Cancer Prevention
-
Guy's and St Thomas' NHS Foundation TrustCompleted
-
University of AberdeenLipton Teas and InfusionsRecruitingThe Focus of the Study is Healthy VolunteersUnited Kingdom
-
University of MinnesotaNational Center for Research Resources (NCRR)Completed
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedProstate CancerUnited States
-
Medstar Health Research InstituteGeorgetown UniversityWithdrawnHypothyroidism | Thyroid CarcinomaUnited States
-
Beth Israel Deaconess Medical CenterNational Center for Complementary and Integrative Health (NCCIH)Completed
-
Unilever R&DLotus Labs Pvt. Ltd, Bangalore, India; Clumax Diagnostics, Bangalore, India; Quipu...Completed
-
Genentech, Inc.CompletedGlioblastoma, GliomaUnited States, Spain
-
University of LuebeckCompleted