Effects of Green Tea Extract on Obese Women With High Level of LDL

Study Overview
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Brief Summary
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Green tea is one of the most popular beverages in the world. It is believed to have beneficial effect in prevention and treatment of many diseases, one of which is reducing LDL-C. The aim of the study is to examine the effect of supplement containing GTE on obese with high LDL level.

Detailed Description
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Randomized, double-blind, crossover placebo-controlled clinical trial

Official Title
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Phase 3 Study; Effects of Green Tea Extract on Obese Women With High Level of Low Density Lipoprotein (LDL): a Randomized, Double-blinded, and Cross-over Placebo-controlled Clinical Trial

Conditions
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Obese, Hyperlipidemia

Intervention / Treatment
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* Dietary Supplement: green tea extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 65 years body mass index (BMI) >= 27 kg/m2 fasting low-density-lipoprotein cholesterol (LDL) >= 130mg/dl and (4) willing to participate in this trial. Exclusion Criteria: serum alanine transaminase > 80 U/L serum creatinine > 1.8 mg/dl breast feeding or pregnancy heart failure, acute myocardial infarction, stroke, heavy injury any other conditions not suitable for trial as evaluated by the physician. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: green tea extract first<br>green tea extract (EGCG) 500mg tid for 6 weeks, then wash-out for 2 weeks, and finally cellulose 500mg tid for 6 weeks total 14 weeks | Dietary Supplement: green tea extract<br>* 500 mg three times per day<br>* Other names: EGCG;Dietary Supplement: Placebo<br>* cellulose 500mg three times a day for 6 weeks<br>* Other names: cellulose;|
| Placebo Comparator: Placebo first<br>cellulose 500mg tid for 6 weeks, then wash-out for 2 weeks, and finally EGCG 500mg tid for 6 weeks total 14 weeks | Dietary Supplement: green tea extract<br>* 500 mg three times per day<br>* Other names: EGCG;Dietary Supplement: Placebo<br>* cellulose 500mg three times a day for 6 weeks<br>* Other names: cellulose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of reduction of LDL-C | level of LDL-C before intervention minus level of LDL-C after intervention equal to reduction of LDL-C, percentage of reduction of LDL-C equal to the level of reduction of LDL-C divided by level of LDL-C before intervention | 6 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDL-C | serum level of high density lipoprotein cholesterol | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obese women, high LDL-C