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

Phase 3

Completed

• Conditions: Obese; Hyperlipidemia
• Interventions: Dietary Supplement: green tea extract; Dietary Supplement: Placebo

• Registration Number: NCT02116517
• Lead Sponsor: National Yang Ming Chiao Tung University

Brief Summary

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

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

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2013-10
• Status Verified: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-15
• Last Update Submitted: 2014-04-15
• Study First Posted: 2014-04-17
• Last Update Posted: 2014-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 73

Inclusion Criteria

1. age between 18 and 65 years
2. body mass index (BMI) >= 27 kg/m2
3. fasting low-density-lipoprotein cholesterol (LDL) >= 130mg/dl and (4) willing to participate in this trial.

Exclusion Criteria

1. serum alanine transaminase > 80 U/L
2. serum creatinine > 1.8 mg/dl
3. breast feeding or pregnancy
4. heart failure, acute myocardial infarction, stroke, heavy injury
5. any other conditions not suitable for trial as evaluated by the physician. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
green tea extract first	green tea extract	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
green tea extract first	Placebo	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
Placebo first	green tea extract	cellulose 500mg tid for 6 weeks, then wash-out for 2 weeks, and finally EGCG 500mg tid for 6 weeks total 14 weeks
Placebo first	Placebo	cellulose 500mg tid for 6 weeks, then wash-out for 2 weeks, and finally EGCG 500mg tid for 6 weeks total 14 weeks

Primary Outcome Measures

Name	Time	Method
percentage of reduction of LDL-C	6 weeks of treatment	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

Secondary Outcome Measures

Name	Time	Method
HDL-C	6 weeks	serum level of high density lipoprotein cholesterol

Trial Locations

Locations (1)

Taipei City Hospital; 🇨🇳 Taipei, Taiwan