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

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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