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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00120107
• Other study ID #: 2003P000089
• Secondary ID: R21AT001899
• Status: Completed
• Phase: N/A
• First received: July 7, 2005
• Last updated: March 10, 2017
• Start date: July 2003
• Est. completion date: April 2005

Study information

• Verified date: March 2017
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• Black Tea

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcomes will be compliance with tea intake and 2 MRI examinations.
Secondary	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.