Cardiovascular DiseaseNCT00120107
Tea's Effect on Atherosclerosis Pilot Study (TEA Study)
A study testing Black Tea in people with Cardiovascular Disease, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The researchers propose a pilot study of the effect of long-term tea intake on atherosclerosis. Thirty patients at high risk for cardiovascular disease will be recruited and randomized to a six-month period of consumption of 3 cups per day of either tea, supplied as black tea solids readily dissolved in hot or cold… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Black Tea
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Apr 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 55 years and the presence of either diabetes or two other cardiovascular risk factors. These risk factors will include hypertension, current smoking, LDL cholesterol ≥ 130 mg/dl, HDL cholesterol <40 mg/dl, or family history of premature coronary heart disease (as defined by Adult Treatment Panel III guidelines).
Who cannot join
- Patients with a history of congestive heart failure, myocardial infarction, arterial revascularization procedure (coronary, carotid, or peripheral), stroke, angina, or intermittent claudication will be excluded from this study. Either self-report or medical record evidence of these diagnoses will suffice for exclusion
- Intolerance or allergy to tea consumption
- Severe claustrophobia or intolerance to previous MRI examinations
- Standard MRI contraindications (for example, a pacemaker, intra-auricular implants, or intracranial clips)
- Severe illness expected to cause death or profound disability within six months
- Uncontrolled hypertension (blood pressure greater than or equal to 180/110)
Show all 11Show fewer
- Chronic renal failure (serum creatinine >2.5 mg/dl or dialysis)
- History of hyponatremia in the last year (sodium <130 mEq/dl)
- Use of vitamin supplements greater than the recommended daily allowance
- Inability to speak English
- Lack of a working telephone
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
The researchers propose a pilot study of the effect of long-term tea intake on atherosclerosis. Thirty patients at high risk for cardiovascular disease will be recruited and randomized to a six-month period of consumption of 3 cups per day of either tea, supplied as black tea solids readily dissolved in hot or cold liquid, or water.
At baseline and after 6 months, atherosclerosis in the aorta will be assessed using magnetic resonance imaging. The primary outcomes of this pilot study will be compliance with tea intake and 2 MRI examinations. As secondary outcomes, standard and novel cardiovascular risk markers, including inflammatory, prothrombotic, fibrinolytic, vascular and metabolic factors will be measured.
If successful, this pilot study will form the basis for a larger, long-term randomized trial to determine the effect of tea consumption on progression of atherosclerosis.
Read the detailed description
Tea is widely thought to have health benefits, particularly on cardiovascular disease (CVD). The investigator's group recently found that intake of 2 or more cups of tea per day was associated with a 44% lower long-term mortality rate than abstention from tea among 1900 patients hospitalized with myocardial infarction. Short-term trials support a benefit of tea on endothelial function, but long-term randomized trials of tea intake on CVD and atherosclerosis are needed to test the effects of tea definitively.
The researchers propose a proof-of-principle pilot study of the effect of long-term tea intake on atherosclerosis. From a large hospital-based primary care practice, 30 patients at high risk for CVD will be recruited and randomized to a six-month period of consumption of 3 cups per day of either tea, supplied as black tea solids readily dissolved in hot or cold liquid, or water. The polyphenol content of these solids will be confirmed at baseline, and a single batch of tea throughout the study will be used. At baseline and after 6 months, aortic atherosclerosis using magnetic resonance imaging, an accurate and reproducible method for measurement of arterial plaque size, will be assessed. Adherence using urinary catechins, the primary flavonoids in tea, will be measured. The primary outcomes will be compliance with tea intake and 2 MRI examinations. As secondary outcomes, standard and novel cardiovascular risk markers, including inflammatory, prothrombotic, fibrinolytic, and metabolic factors will be measured. The researchers will also assess the effects of tea consumption on oxidizability of LDL and VLDL cholesterol, using a novel affinity-column chromatography approach, and on endothelial integrity, as assessed by serum markers of endothelial function. If successful, this pilot study will form the basis for a larger, long-term randomized trial to determine the effect of tea consumption on progression of atherosclerosis.
- Conditions
- Cardiovascular Disease
- Being tested
- Black Tea
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black TeaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcomes will be compliance with tea intake and 2 MRI examinations.
Secondary outcomes (1)
Standard and novel cardiovascular risk markers, including inflammatory, prothrombotic, fibrinolytic, serum markers of endothelial function and metabolic factors. We will also assess oxidizability of LDL and VLDL cholesterol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2005 (estimated)
- Study startJul 2003
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Kenneth Mukamal, Beth Israel Deaconess Medical Center
- Investigators
- Murray A Mittleman, MD, DrPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120107
- Sponsor's protocol ID
- 2003P000089
- Other IDs
- R21AT001899
- Status last verified
- Mar 2017
- First submitted
- 7 Jul 2005
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mukamal KJ, MacDermott K, Vinson JA, Oyama N, Manning WJ, Mittleman MA. A 6-month randomized pilot study of black tea and cardiovascular risk factors. Am Heart J. 2007 Oct;154(4):724.e1-6. doi: 10.1016/j.ahj.2007.07.008.
PubMed 17892999
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tea's Effect on Atherosclerosis Pilot Study (TEA Study)
- ClinicalTrials.gov ID
- NCT00120107
- Acronym / sponsor ID
- 2003P000089
- Conditions
- Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jul 2003
- Study completion
- Apr 2005 (actual)
- First posted
- 15 Jul 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.
The researchers propose a pilot study of the effect of long-term tea intake on atherosclerosis. Thirty patients at high risk for cardiovascular disease will be recruited and randomized to a six-month period of consumption of 3 cups per day of either tea, supplied as black tea solids readily dissolved in hot or cold liquid, or water.
At baseline and after 6 months, atherosclerosis in the aorta will be assessed using magnetic resonance imaging. The primary outcomes of this pilot study will be compliance with tea intake and 2 MRI examinations. As secondary outcomes, standard and novel cardiovascular risk markers, including inflammatory, prothrombotic, fibrinolytic, vascular and metabolic factors will be measured.
If successful, this pilot study will form the basis for a larger, long-term randomized trial to determine the effect of tea consumption on progression of atherosclerosis.
Detailed description
Tea is widely thought to have health benefits, particularly on cardiovascular disease (CVD). The investigator's group recently found that intake of 2 or more cups of tea per day was associated with a 44% lower long-term mortality rate than abstention from tea among 1900 patients hospitalized with myocardial infarction. Short-term trials support a benefit of tea on endothelial function, but long-term randomized trials of tea intake on CVD and atherosclerosis are needed to test the effects of tea definitively.
The researchers propose a proof-of-principle pilot study of the effect of long-term tea intake on atherosclerosis. From a large hospital-based primary care practice, 30 patients at high risk for CVD will be recruited and randomized to a six-month period of consumption of 3 cups per day of either tea, supplied as black tea solids readily dissolved in hot or cold liquid, or water. The polyphenol content of these solids will be confirmed at baseline, and a single batch of tea throughout the study will be used. At baseline and after 6 months, aortic atherosclerosis using magnetic resonance imaging, an accurate and reproducible method for measurement of arterial plaque size, will be assessed. Adherence using urinary catechins, the primary flavonoids in tea, will be measured. The primary outcomes will be compliance with tea intake and 2 MRI examinations. As secondary outcomes, standard and novel cardiovascular risk markers, including inflammatory, prothrombotic, fibrinolytic, and metabolic factors will be measured. The researchers will also assess the effects of tea consumption on oxidizability of LDL and VLDL cholesterol, using a novel affinity-column chromatography approach, and on endothelial integrity, as assessed by serum markers of endothelial function. If successful, this pilot study will form the basis for a larger, long-term randomized trial to determine the effect of tea consumption on progression of atherosclerosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age greater than or equal to 55 years and the presence of either diabetes or two other cardiovascular risk factors. These risk factors will include hypertension, current smoking, LDL cholesterol ≥ 130 mg/dl, HDL cholesterol <40 mg/dl, or family history of premature coronary heart disease (as defined by Adult Treatment Panel III guidelines).
Key exclusion criteria (11 listed)
- Patients with a history of congestive heart failure, myocardial infarction, arterial revascularization procedure (coronary, carotid, or peripheral), stroke, angina, or intermittent claudication will be excluded from this study. Either self-report or medical record evidence of these diagnoses will suffice for exclusion
- Intolerance or allergy to tea consumption
- Severe claustrophobia or intolerance to previous MRI examinations
- Standard MRI contraindications (for example, a pacemaker, intra-auricular implants, or intracranial clips)
- Severe illness expected to cause death or profound disability within six months
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 |
|---|---|---|
| Black Tea | Drug | – |
Primary outcome
The primary outcomes will be compliance with tea intake and 2 MRI examinations.
1 secondary outcome
Standard and novel cardiovascular risk markers, including inflammatory, prothrombotic, fibrinolytic, serum markers of endothelial function and metabolic factors. We will also assess oxidizability of LDL and VLDL cholesterol.
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 14 Mar 2017.
- Results publication: PubMed 17892999Mukamal KJ, MacDermott K, Vinson JA, Oyama N, Manning WJ, Mittleman MA. A 6-month randomized pilot study of black tea and cardiovascular risk factors. Am Heart J. 2007 Oct;154(4):724.e1-6. doi: 10.1016/j.ahj.2007.07.008.
- Individual participant dataSharing planned: Undecided
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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.
Murray A Mittleman, MD, DrPH principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black Tea in people with Cardiovascular Disease, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 1 inclusion and 11 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 14 Mar 2017. 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 United States. 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 primary outcomes will be compliance with tea intake and 2 MRI examinations.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00120107, which also lists 1 linked publication.
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 14 Mar 2017.