Tea's Effect on Atherosclerosis Pilot Study (TEA Study)

Completed · Not applicable

Conditions studied: Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT00120107

Run by

Beth Israel Deaconess Medical Center

People needed

30

Starts

2003-07-01

Expected to finish

2005-04-01

Last updated by the study team

2017-03-14

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.