Status:
COMPLETED
Tea's Effect on Atherosclerosis Pilot Study (TEA Study)
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
55+ years
Phase:
NA
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00120107
Start Date
July 1 2003
End Date
April 1 2005
Last Update
March 14 2017
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215