Effects of Green Tea Extract on Obese Women With High Level of LDL (GTE-LDL)

National Yang Ming Chiao Tung University

Status and phase: Completed; Phase 3

Conditions: Obese; Hyperlipidemia

Treatments: Dietary Supplement: green tea extract; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02116517

100WFA2200449

Details and patient eligibility

About

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.

Full description

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

Enrollment: 73 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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73 participants in 2 patient groups, including a placebo group

green tea extract first

Experimental group

Description:

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

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: green tea extract

Placebo first

Placebo Comparator group

Description:

cellulose 500mg tid for 6 weeks, then wash-out for 2 weeks, and finally EGCG 500mg tid for 6 weeks total 14 weeks

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: green tea extract