Combination Treatment With Green Tea Extract and Statins in Patients With Hypercholesterolemia (GTE-Stat)

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.

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Dietary supplement: Green Tea Extract - Catechins; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Greece
  • Thessaly
    • Trikala, Thessaly, Greece, 42100
      • General Hospital of Trikala

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in Total CHO and LDH	12 wks

Secondary Outcome Measures

Outcome Measure	Time Frame
lipids profile, body composition, visceral adiposity, Redox status, glucose disposal, Insulin sensitivity index, liver fat infiltration, quality of life parameters	12 wks

Collaborators and Investigators

• Sponsor: University of Thessaly
• Collaborators: Greek Ministry of Development; General Hospital of Trikala, Dept of Internal Medicine; University General Hospital of Larissa, Dept of Medicine
• Investigators: Principal Investigator: Giorgos K Sakkas, PhD, UTH - CERETETH; Principal Investigator: Christina Karatzaferi, PhD, University of Thessaly

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: July 21, 2009
• First Submitted That Met QC Criteria: July 22, 2009
• First Posted (Estimate): July 23, 2009

Study Record Updates

• Last Update Posted (Estimate): December 3, 2010
• Last Update Submitted That Met QC Criteria: December 2, 2010
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: quality of life; body composition; oxidative stress; Statin; visceral fat; steatosis; atorvastatin; OGTT; Green Tea Extract; Catechins; OGIS; ISI matsuda
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: 3-22/846/06-2007; 22/08-06-2007; no3/10-01-2007; 846/22/15-06-2007