NCT00383058

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3 obesity

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_3 obesity

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2006

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 2, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

September 1, 2009

Status Verified

August 1, 2009

First QC Date

September 29, 2006

Last Update Submit

August 31, 2009

Conditions

Obesity

Keywords

obesitygreen tea

Outcome Measures

Primary Outcomes (1)

  • (Percent) reduction of body mass index and body weight

Secondary Outcomes (2)

  • (Percent) reduction of: Glucose, cholesterol,LDL, HDL and triglyceride

  • leptin, adiponectin and ghrelin comparisons and analysis

Interventions

the extract of green teaDRUG

Eligibility Criteria

Age16 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Hospital

Taipei, 886, Taiwan

Location

Related Publications (1)

  • 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: 18468736DERIVED

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chung-Hua Hsu, MD, PhD

    Chinese Medicine Dep, Taipei Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 29, 2006

First Posted

October 2, 2006

Study Start

September 1, 2006

Study Completion

June 1, 2007

Last Updated

September 1, 2009

Record last verified: 2009-08

Locations

TW(1)