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

Hypercholesterolemia Clinical Trial

— GTE-Stat  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944827
• Other study ID #: 3-22/846/06-2007
• Secondary ID: 22/08-06-2007no3
• Status: Completed
• Phase: Phase 2
• First received: July 21, 2009
• Last updated: December 2, 2010
• Start date: September 2007
• Est. completion date: October 2009

Study information

• Verified date: July 2009
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Green Tea Extract - Catechins
Combination treatment with 20 mg atorvastatin and 600mg green tea extract, daily for 12 weeks
• Placebo
Combination treatment with 20 mg atorvastatin and 600mg placebo, daily for 12 weeks

Locations

Country	Name	City	State
Greece	General Hospital of Trikala	Trikala	Thessaly

Sponsors (4)

Lead Sponsor	Collaborator
University of Thessaly	General Hospital of Trikala, Dept of Internal Medicine, Greek Ministry of Development, University General Hospital of Larissa, Dept of Medicine

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Total CHO and LDH		12 wks	Yes
Secondary	lipids profile, body composition, visceral adiposity, Redox status, glucose disposal, Insulin sensitivity index, liver fat infiltration, quality of life parameters		12 wks	No