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

July 21, 2009
December 2, 2010
September 2007
October 2009   (final data collection date for primary outcome measure)
Reduction in Total CHO and LDH [ Time Frame: 12 wks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00944827 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Combination Treatment With Green Tea Extract and Statins in Patients With Hypercholesterolemia
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Hypercholesterolemia
  • Dietary Supplement: Green Tea Extract - Catechins
    Combination treatment with 20 mg atorvastatin and 600mg green tea extract, daily for 12 weeks
  • Dietary Supplement: Placebo
    Combination treatment with 20 mg atorvastatin and 600mg placebo, daily for 12 weeks
  • Experimental: GTE
    The experimental group will receive 20 mg atorvastatin (Lipitor) daily and 600 mg. of pure catechin in capsules
    Intervention: Dietary Supplement: Green Tea Extract - Catechins
  • Placebo Comparator: CON
    The control group will receive 20 mg atorvastatin (Lipitor) and Placebo in identical capsules containing 600 mg placebo for 12 weeks
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT00944827
3-22/846/06-2007, 22/08-06-2007, no3/10-01-2007, 846/22/15-06-2007
No
Dr. Giorgos K. Sakkas, CERETETH - PerfoTech - ClinLab
University of Thessaly
  • Greek Ministry of Development
  • General Hospital of Trikala, Dept of Internal Medicine
  • University General Hospital of Larissa, Dept of Medicine
Principal Investigator: Giorgos K Sakkas, PhD UTH - CERETETH
Principal Investigator: Christina Karatzaferi, PhD University of Thessaly
University of Thessaly
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP