Combination Treatment With Green Tea Extract and Statins in Patients With Hypercholesterolemia
NCT00944827 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2010-12-03
Summary
There is a positive correlation between serum's cholesterol levels and death from cardiovascular disease, especially coronary artery disease. The reduction of plasma lipids levels is one of the main goals of prevention. Research has shown that green tea has beneficial effects on health due to the polyphenolic substances (catechins) that it contains. Studies have shown that prolonged consumption of polyphenols has a positive effect on factors related to cardiovascular risk such as obesity, dislipidemia and various indicators of oxidative stress.
The aim of this study was to examine the possible effects of catechin supplementation, in combination with the classic treatment for the reduction of hypercholesterolemia, statin therapy, on the treatment's effectiveness and in the reduction of classic side effects.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
Green Tea Extract - Catechins
Combination treatment with 20 mg atorvastatin and 600mg green tea extract, daily for 12 weeks
- DIETARY_SUPPLEMENT
-
Placebo
Combination treatment with 20 mg atorvastatin and 600mg placebo, daily for 12 weeks
Sponsors & Collaborators
-
Greek Ministry of Development
collaborator OTHER_GOV -
General Hospital of Trikala, Dept of Internal Medicine
collaborator UNKNOWN -
University General Hospital of Larissa, Dept of Medicine
collaborator UNKNOWN -
University of Thessaly
lead OTHER
Principal Investigators
-
Giorgos K Sakkas, PhD · UTH - CERETETH
-
Christina Karatzaferi, PhD · University of Thessaly
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-09-30
- Primary Completion
- 2009-10-31
- Completion
- 2009-10-31
Countries
- Greece
Study Locations
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