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

Primary Purpose

Obese, Hyperlipidemia

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
green tea extract
Placebo
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obese focused on measuring obese women, high LDL-C

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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. -

Sites / Locations

  • Taipei City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

green tea extract first

Placebo first

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

HDL-C
serum level of high density lipoprotein cholesterol

Full Information

First Posted
April 4, 2014
Last Updated
April 15, 2014
Sponsor
National Yang Ming University
Collaborators
Taipei City Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02116517
Brief Title
Effects of Green Tea Extract on Obese Women With High Level of LDL
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University
Collaborators
Taipei City Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obese, Hyperlipidemia
Keywords
obese women, high LDL-C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
green tea extract first
Arm Type
Experimental
Arm 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
Arm Title
Placebo first
Arm Type
Placebo Comparator
Arm Description
cellulose 500mg tid for 6 weeks, then wash-out for 2 weeks, and finally EGCG 500mg tid for 6 weeks total 14 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
green tea extract
Other Intervention Name(s)
EGCG
Intervention Description
500 mg three times per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
cellulose
Intervention Description
cellulose 500mg three times a day for 6 weeks
Primary Outcome Measure Information:
Title
percentage of reduction of LDL-C
Description
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
Time Frame
6 weeks of treatment
Secondary Outcome Measure Information:
Title
HDL-C
Description
serum level of high density lipoprotein cholesterol
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chung-Hua Hsu, PhD, MD
Organizational Affiliation
Taipei City Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Taipei City Hospital
City
Taipei
ZIP/Postal Code
886
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24614112
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.
Results Reference
background
PubMed Identifier
21649457
Citation
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.
Results Reference
background
PubMed Identifier
18468736
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.
Results Reference
background
PubMed Identifier
30400924
Citation
Huang LH, Liu CY, Wang LY, Huang CJ, Hsu CH. Effects of green tea extract on overweight and obese women with high levels of low density-lipoprotein-cholesterol (LDL-C): a randomised, double-blind, and cross-over placebo-controlled clinical trial. BMC Complement Altern Med. 2018 Nov 6;18(1):294. doi: 10.1186/s12906-018-2355-x.
Results Reference
derived
Links:
URL
http://www.ym.edu.tw/tra/Chung-Hua%20Hsu-e.htm
Description
web of Chung-Hua Hsu

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

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