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

NCT00120107 | Completed

• 2 other identifiers: 2003P000089R21AT001899
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

Black Tea DRUG

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related 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. doi: 10.1016/j.ahj.2007.07.008.

  PMID: 17892999 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Murray A Mittleman, MD, DrPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 7, 2005
• First Posted: July 15, 2005
• Study Start: July 1, 2003
• Study Completion: April 1, 2005
• Last Updated: March 14, 2017

Record last verified: 2017-03

Locations

US (1)