Cardiac DiseaseNCT00114907
Effects of Black Tea on Cardiovascular Disease in the Mauritian Population
A study testing Consumption of black tea in people with Cardiac Disease, run by University of Mauritius at 1 site in Mauritius.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Consumption of black tea
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 270 participants
- Where
- 1 siteMauritius
- Study dates
- Jun 2005to Jun 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 25-70 years
- Non smokers
- Left ventricular ejection fraction>40%
Who cannot join
- Alcohol consumption > 4 standard drinks/day
- Postmenopausal women receiving hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Cardiac Disease
- Being tested
- Consumption of black tea
- Keywords
- Tea, Oxidative stress markers, cardiovascular disease, polyphenolics, double blind, Ischaemic cardiac disease
- Medical subject headings
- Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consumption of black teaBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2005 (estimated)
- Study startJun 2005
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 270 participants
Sponsor and investigators
- Lead sponsor
- University of Mauritius
- Sponsor type
- University, hospital or other
- Collaborators
- Mauritius Research Council, Cardiac Centre, Pamplemousses, London South Bank University
- Investigators
- Theeshan Bahorun, PhD, Principal investigator, University of Mauritius
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114907
- Sponsor's protocol ID
- TEA
- Other IDs
- MRC/RUN-0408
- Status last verified
- Jun 2005
- First submitted
- 17 Jun 2005
- Last updated
- 6 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Black Tea on Cardiovascular Disease in the Mauritian Population
- ClinicalTrials.gov ID
- NCT00114907
- Acronym / sponsor ID
- TEA
- Conditions
- Cardiac Disease
- Keywords
- Tea, Oxidative stress markers, cardiovascular disease, polyphenolics, double blind, Ischaemic cardiac disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants
- Lead sponsor
- University of MauritiusUniversity, hospital or other
- Collaborators
- Mauritius Research Council, Cardiac Centre, Pamplemousses, London South Bank University
- Study start
- Jun 2005
- Study completion
- Jun 2005
- First posted
- 20 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 25-70 years
- Non smokers
- Left ventricular ejection fraction>40%
Key exclusion criteria (2 listed)
- Alcohol consumption > 4 standard drinks/day
- Postmenopausal women receiving hormone replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consumption of black tea | Behavioural | – |
Primary outcome
The study will assess the effect of tea consumption on the incidence of cardiovascular diseases
1 secondary outcome
The effect of tea consumption will be evaluated on a number of markers of oxidative stress associated with cardiovascular disease
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theeshan Bahorun, PhD principal investigator
University of Mauritius
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consumption of black tea in people with Cardiac Disease, run by University of Mauritius at 1 site in Mauritius.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mauritius. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The study will assess the effect of tea consumption on the incidence of cardiovascular diseases. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2007.