Combination Treatment With Green Tea Extract and Statins in Patients With Hypercholesterolemia (GTE-Stat)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Dietary Supplement: Green Tea Extract - Catechins Dietary Supplement: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
| Official Title: | The Effects of Catechin Supplementation (Green Tea Extract), 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. |
- Reduction in Total CHO and LDH [ Time Frame: 12 wks ] [ Designated as safety issue: Yes ]
- lipids profile, body composition, visceral adiposity, Redox status, glucose disposal, Insulin sensitivity index, liver fat infiltration, quality of life parameters [ Time Frame: 12 wks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2007 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: GTE
The experimental group will receive 20 mg atorvastatin (Lipitor) daily and 600 mg. of pure catechin in capsules
|
Dietary Supplement: Green Tea Extract - Catechins
Combination treatment with 20 mg atorvastatin and 600mg green tea extract, daily for 12 weeks
|
|
Placebo Comparator: CON
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 placebo, daily for 12 weeks
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Total cholesterol >200mg/dl, or LDL >160 mg/dl
Exclusion Criteria:
- normal lipidemic profile, on statin medication, diabetes mellitus, liver disease, severe hypertension, pregnancy, or severe side effects after 4 weeks of treatment
Contacts and Locations| Greece | |
| General Hospital of Trikala | |
| Trikala, Thessaly, Greece, 42100 | |
| Principal Investigator: | Giorgos K Sakkas, PhD | UTH - CERETETH |
| Principal Investigator: | Christina Karatzaferi, PhD | University of Thessaly |
More Information
No publications provided
| Responsible Party: | Dr. Giorgos K. Sakkas, CERETETH - PerfoTech - ClinLab |
| ClinicalTrials.gov Identifier: | NCT00944827 History of Changes |
| Other Study ID Numbers: | 3-22/846/06-2007, 22/08-06-2007, no3/10-01-2007, 846/22/15-06-2007 |
| Study First Received: | July 21, 2009 |
| Last Updated: | December 2, 2010 |
| Health Authority: | Greece: Ministry of Health and Welfare |
Keywords provided by University of Thessaly:
|
Green Tea Extract Catechins Statin atorvastatin body composition visceral fat |
steatosis oxidative stress quality of life OGTT OGIS ISI matsuda |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013