NCT02147041

Brief Summary

The aim of this study is to examine the therapeutic effect of green tea extract on obese women and the correlation analysis between traditional Chinese medicine syndrome and obese related hormone peptides.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for phase_2 diabetes-mellitus

Timeline
Completed

Started May 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 26, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

May 26, 2014

Status Verified

May 1, 2014

Enrollment Period

2.3 years

First QC Date

January 20, 2014

Last Update Submit

May 21, 2014

Conditions

Diabetes MellitusHyperlipidemia

Keywords

diabetes mellitushyperlipidemiagreen teaepigallocatechin gallate

Outcome Measures

Primary Outcomes (1)

  • composite of anthropometric measures

    composite include body weight, waist circumference, hip circumference

    compare between the beginning of the study and after 12 weeks of treatment.

Secondary Outcomes (4)

  • Hormone peptide change

    compared between the beginning of the study and after 12 weeks of treatment

  • biochemical characteristic change

    compare between the beginning of the study and after 12 weeks of treatment.

  • traditional chinese medicine syndrome classification

    compare between the beginning of the study and after 12 weeks of treatment.

  • Quality of life evaluation

    compare between the beginning of the study and after 12 weeks of treatment.

Study Arms (2)

EGCG(Epigallocatechin Gallate)

EXPERIMENTAL

EGCG(Epigallocatechin Gallate)(500 mg, three times a day, 12 weeks)

Drug: EGCG(Epigallocatechin Gallate)

placebo

PLACEBO COMPARATOR

cellulose (500mg, three times a day, 12 weeks)

Drug: Placebo

Interventions

EGCG(Epigallocatechin Gallate)DRUG

500mg, three times a day, duration:12 weeks

Also known as: EGCG-Epigallocatechin Gallate, green tea extract, cellulose-cellulose
EGCG(Epigallocatechin Gallate)
PlaceboDRUG
placebo

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • aged between 20 and 60 years old women
  • Chinese
  • body mass index (BMI) \> 27 kg/m2
  • waist circumference (WC) \> 80 cm
  • willing to participate in and fill out the questionnaires for this trial.

You may not qualify if:

  • GPT \> 80 U/L, serum creatinine \> 2.0 mg/dl
  • breast feeding or pregnancy
  • heart failure
  • acute myocardial infarction
  • Stroke
  • any other conditions not suitable for trial as evaluated by the physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei City Hospital

Taipei, Taiwan, Taiwan

Location

Related Publications (2)

  • 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.

    PMID: 18468736RESULT

  • Chen IJ, Liu CY, Chiu JP, Hsu CH. Therapeutic effect of high-dose green tea extract on weight reduction: A randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2016 Jun;35(3):592-9. doi: 10.1016/j.clnu.2015.05.003. Epub 2015 May 29.

    PMID: 26093535DERIVED

MeSH Terms

Conditions

Diabetes MellitusHyperlipidemias

Interventions

TeaCellulose

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDyslipidemiasLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesGlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Chung-Hua Hsu, PHD

    Taipei medical hospital, Linsen Chinese Medicine branch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of medical affairs

Study Record Dates

First Submitted

January 20, 2014

First Posted

May 26, 2014

Study Start

May 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

May 26, 2014

Record last verified: 2014-05

Locations

TW(1)