The Extract of Green Tea on Obese Women: a Randomized Dou... | NCT00383058

Studies
The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial

NCT00383058

Sponsor

Taipei City Hospital

Status

Completed

Last Update Posted

Sep 1, 2009Estimated

Enrollment

100

Phase

Phase 3

Conditions

Obesity

Interventions

the extract of green tea

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NSC-95-2320-B-192-001

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Not provided

Completion Date

Jun 2007Actual

First Submitted Date

Sep 29, 2006

First Submission Date that Met QC Criteria

Sep 29, 2006

First Posted Date

Oct 2, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2009

Last Update Posted Date

Sep 1, 2009Estimated

Name	Class
National Science and Technology Council, Taiwan	OTHER_GOV
Taipei Hospital, Taiwan	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to examine whether the extract of the green tea is effective on obese women.

Detailed Description

We conducted the pilot study in 2005. The initial findings showed the extract of green tea is benefit on obese women. The potential benefit include appetite lowing, lipid markers decreasing and regulating balance of obese related hormone peptides. So we designed this trial.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Name	Type	Description	Arm Group Labels	Other Names
the extract of green tea	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
(Percent) reduction of body mass index and body weight

Secondary Outcomes

Measure	Description	Time Frame
(Percent) reduction of: Glucose, cholesterol,LDL, HDL and triglyceride
leptin, adiponectin and ghrelin comparisons and analysis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 16-60 years old female
BMI>27㎞/m2
Signed informed consent

Exclusion Criteria:

Endocrine disease, e.g. thyroid disorder, pituitary disorder, and sex gland disorder.
Heart disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker.
Allergy and Immunology disease.
High aminotransferases ( Alanine, Aspartate >80 IU/L) or high serum Creatinine (>2.5 mg/dL)
Pregnant or lactating women.
Childbirth within 6 months.
Stroke or otherwise unable to exercise
Management for weight control within 3 months.
Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chung-Hua Hsu, MD, PhD	Chinese Medicine Dep, Taipei Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Hospital		Taipei		886	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18468736	Derived	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.

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases