A Phase 2 interventional study of Green Tea Extract - Catechins and Placebo in Hypercholesterolemia, sponsored by University of Thessaly. Completed at 1 site in Greece. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-12-03.
Sponsored by University of Thessaly · Phase 2, Interventional, and Supportive care
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.
This is a randomized, double - blind placebo controlled trial. The patients will be divided randomly in two groups; one group will receive statin and catechin, while the other statin and placebo for 12 weeks. The experimental group will receive 20 mg atorvastatin (Lipitor) daily and 600 mg of catechin in capsules, while the control group will receive 20 mg atorvastatin (Lipitor) and Placebo in identical capsules of 600 mg for the same time period.
The patients will undergo biochemical evaluation in which the serum lipids, the levels of oxidative stress and the antioxidant capacity will be assessed. Body composition will be calculated with anthropometric measurements, while the levels of visceral fat, the subcutaneous fat, as well as the level of liver fat infiltration will be examined with the use of computed tomography images. Factors related to the patients' quality of life will be assessed by a series of questionnaires.
The investigators hypothesized that the combination treatment with statin and green tea extract (catechins)will improve in a greater extent the lipidemic profile, increase antioxidant capacity, reducing significantly visceral fat and intrahepatic lipids content.
1,238 studies on the registry are indexed under Hypercholesterolemia; 110 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 992 interventional studies indexed under Hypercholesterolemia.
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The experimental group will receive 20 mg atorvastatin (Lipitor) daily and 600 mg. of pure catechin in capsules
Dietary Supplement: Green Tea Extract - Catechins
The control group will receive 20 mg atorvastatin (Lipitor) and Placebo in identical capsules containing 600 mg placebo for 12 weeks
Dietary Supplement: Placebo
Combination treatment with 20 mg atorvastatin and 600mg green tea extract, daily for 12 weeks
Combination treatment with 20 mg atorvastatin and 600mg placebo, daily for 12 weeks
Reduction in Total CHO and LDH
Time frame: 12 wks
lipids profile, body composition, visceral adiposity, Redox status, glucose disposal, Insulin sensitivity index, liver fat infiltration, quality of life parameters
Time frame: 12 wks
This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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University of Thessaly