Combination Treatment With Green Tea Extract and Statins in Patients With Hypercholesterolemia
GTE-Stat
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.
4 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 21, 2009
CompletedFirst Posted
Study publicly available on registry
July 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedDecember 3, 2010
July 1, 2009
2.1 years
July 21, 2009
December 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in Total CHO and LDH
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
12 wks
Study Arms (2)
GTE
EXPERIMENTALThe experimental group will receive 20 mg atorvastatin (Lipitor) daily and 600 mg. of pure catechin in capsules
CON
PLACEBO COMPARATORThe control group will receive 20 mg atorvastatin (Lipitor) and Placebo in identical capsules containing 600 mg placebo for 12 weeks
Interventions
Combination treatment with 20 mg atorvastatin and 600mg green tea extract, daily for 12 weeks
Combination treatment with 20 mg atorvastatin and 600mg placebo, daily for 12 weeks
Eligibility Criteria
You may qualify if:
- Total cholesterol \>200mg/dl, or LDL \>160 mg/dl
You may not qualify if:
- normal lipidemic profile, on statin medication, diabetes mellitus, liver disease, severe hypertension, pregnancy, or severe side effects after 4 weeks of treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
General Hospital of Trikala
Trikala, Thessaly, 42100, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giorgos K Sakkas, PhD
UTH - CERETETH
- PRINCIPAL INVESTIGATOR
Christina Karatzaferi, PhD
University of Thessaly
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 21, 2009
First Posted
July 23, 2009
Study Start
September 1, 2007
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
December 3, 2010
Record last verified: 2009-07