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Combination Treatment With Green Tea Extract and Statins in Patients With Hypercholesterolemia

NCT ID: NCT00944827

Last Updated: 2010-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypercholesterolemia

Keywords

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Green Tea Extract Catechins Statin atorvastatin body composition visceral fat steatosis oxidative stress quality of life OGTT OGIS ISI matsuda

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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GTE

The experimental group will receive 20 mg atorvastatin (Lipitor) daily and 600 mg. of pure catechin in capsules

Group Type EXPERIMENTAL

Green Tea Extract - Catechins

Intervention Type DIETARY_SUPPLEMENT

Combination treatment with 20 mg atorvastatin and 600mg green tea extract, daily for 12 weeks

CON

The control group will receive 20 mg atorvastatin (Lipitor) and Placebo in identical capsules containing 600 mg placebo for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Combination treatment with 20 mg atorvastatin and 600mg placebo, daily for 12 weeks

Interventions

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Green Tea Extract - Catechins

Combination treatment with 20 mg atorvastatin and 600mg green tea extract, daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Combination treatment with 20 mg atorvastatin and 600mg placebo, daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Greek Ministry of Development

OTHER_GOV

Sponsor Role collaborator

General Hospital of Trikala, Dept of Internal Medicine

UNKNOWN

Sponsor Role collaborator

University General Hospital of Larissa, Dept of Medicine

UNKNOWN

Sponsor Role collaborator

University of Thessaly

OTHER

Sponsor Role lead

Responsible Party

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CERETETH - PerfoTech - ClinLab

Principal Investigators

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Giorgos K Sakkas, PhD

Role: PRINCIPAL_INVESTIGATOR

UTH - CERETETH

Christina Karatzaferi, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Thessaly

Locations

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General Hospital of Trikala

Trikala, Thessaly, Greece

Site Status

Countries

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Greece

Other Identifiers

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22/08-06-2007

Identifier Type: -

Identifier Source: secondary_id

no3/10-01-2007

Identifier Type: -

Identifier Source: secondary_id

846/22/15-06-2007

Identifier Type: -

Identifier Source: secondary_id

3-22/846/06-2007

Identifier Type: -

Identifier Source: org_study_id