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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.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00944827
Acronym
GTE-Stat
Enrollment
40
Registered
2009-07-23
Start date
2007-09-30
Completion date
2009-10-31
Last updated
2010-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

Green Tea Extract, Catechins, Statin, atorvastatin, body composition, visceral fat, steatosis, oxidative stress, quality of life, OGTT, OGIS, ISI matsuda

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.

Interventions

DIETARY_SUPPLEMENTGreen Tea Extract - Catechins

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

DIETARY_SUPPLEMENTPlacebo

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

Sponsors

Greek Ministry of Development
CollaboratorOTHER_GOV
General Hospital of Trikala, Dept of Internal Medicine
CollaboratorUNKNOWN
University General Hospital of Larissa, Dept of Medicine
CollaboratorUNKNOWN
University of Thessaly
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Reduction in Total CHO and LDH12 wks

Secondary

MeasureTime frame
lipids profile, body composition, visceral adiposity, Redox status, glucose disposal, Insulin sensitivity index, liver fat infiltration, quality of life parameters12 wks

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026