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

This study has been completed.
Sponsor:
Collaborators:
Greek Ministry of Development
General Hospital of Trikala, Dept of Internal Medicine
University General Hospital of Larissa, Dept of Medicine
Information provided by:
University of Thessaly
ClinicalTrials.gov Identifier:
NCT00944827
First received: July 21, 2009
Last updated: December 2, 2010
Last verified: July 2009
  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.

Resource links provided by NLM:


Further study details as provided by University of Thessaly:

Primary Outcome Measures:
  • Reduction in Total CHO and LDH [ Time Frame: 12 wks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944827

Locations
Greece
General Hospital of Trikala
Trikala, Thessaly, Greece, 42100
Sponsors and Collaborators
University of Thessaly
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
  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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014