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NCT Number: NCT00944827

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

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.

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Key information

Conditions

Hypercholesterolemia Digestive System Diseases Dyslipidemias Fatty Liver Hyperlipidemias Lipid Metabolism Disorders Liver Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

General Hospital of Trikala

Trikala, Thessaly, 42100, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Green Tea Extract - Catechins

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. Reduction in Total CHO and LDH

    Time frame: 12 wks

Secondary outcomes

  1. lipids profile, body composition, visceral adiposity, Redox status, glucose disposal, Insulin sensitivity index, liver fat infiltration, quality of life parameters

    Time frame: 12 wks

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Collaborators

  • General Hospital of Larissa
  • General Hospital of Trikala, Dept of Internal Medicine
  • Greek Ministry of Development

Registry information

Official study 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.

Acronym: GTE-Stat

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 23, 2009
Registry last updated
Dec 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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