Clinical trial NCT00944827: Combination Treatment With Green Tea Extract and Statins in Patients With Hypercholesterolemia
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Keywords: Green Tea Extract
Catechins
Statin
atorvastatin
body composition
visceral fat
steatosis
oxidative stress
quality of life
OGTT
OGIS
ISI matsuda
Lead sponsor: University of Thessaly
Sponsor class: OTHER
Collaborators: name: Greek Ministry of Development
name: General Hospital of Trikala, Dept of Internal Medicine
name: University General Hospital of Larissa, Dept of Medicine
First posted: 2009-07-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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

Primary outcomes:
measure: Reduction in Total CHO and LDH
timeFrame: 12 wks
Secondary outcomes:
measure: lipids profile, body composition, visceral adiposity, Redox status, glucose disposal, Insulin sensitivity index, liver fat infiltration, quality of life parameters
timeFrame: 12 wks
Other outcomes:
Locations:
city: Trikala
country: Greece
facility: General Hospital of Trikala
state: Thessaly
Study officials:
affiliation: UTH - CERETETH
name: Giorgos K Sakkas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Thessaly
name: Christina Karatzaferi, PhD
role: PRINCIPAL_INVESTIGATOR
References: