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

Hyperlipidemia Clinical Trial

— GTE-LDL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116517
• Other study ID #: 100WFA2200449
• Status: Completed
• Phase: Phase 3
• First received: April 4, 2014
• Last updated: April 15, 2014
• Start date: August 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Obese

Intervention

Dietary Supplement:
• green tea extract
500 mg three times per day
• Placebo
cellulose 500mg three times a day for 6 weeks

Locations

Country	Name	City	State
Taiwan	Taipei City Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Yang Ming University	Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Hsu CH, Liao YL, Lin SC, Tsai TH, Huang CJ, Chou P. Does supplementation with green tea extract improve insulin resistance in obese type 2 diabetics? A randomized, double-blind, and placebo-controlled clinical trial. Altern Med Rev. 2011 Jun;16(2):157-63. — View Citation

Hsu CH, Tsai TH, Kao YH, Hwang KC, Tseng TY, Chou P. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2008 Jun;27(3):363-70. doi: 10.1016/j.clnu.2008.03.007. Epub 2008 May 12. — View Citation

Liu CY, Huang CJ, Huang LH, Chen IJ, Chiu JP, Hsu CH. Effects of green tea extract on insulin resistance and glucagon-like peptide 1 in patients with type 2 diabetes and lipid abnormalities: a randomized, double-blinded, and placebo-controlled trial. PLoS One. 2014 Mar 10;9(3):e91163. doi: 10.1371/journal.pone.0091163. eCollection 2014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	HDL-C	serum level of high density lipoprotein cholesterol	6 weeks	No

External Links

•   web of Chung-Hua Hsu