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

NCT ID: NCT00383058

Last Updated: 2009-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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the extract of green tea

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age 16-60 years old female
2. BMI\>27㎞/m2
3. Signed informed consent

Exclusion Criteria

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

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

Taipei Hospital, Taiwan

OTHER

Sponsor Role collaborator

Taipei City Hospital

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Chung-Hua Hsu, MD, PhD

Role: STUDY_DIRECTOR

Chinese Medicine Dep, Taipei Hospital

Locations

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Taipei Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 18468736 (View on PubMed)

Other Identifiers

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NSC-95-2320-B-192-001

Identifier Type: -

Identifier Source: secondary_id

TH-Greentea-06-01

Identifier Type: -

Identifier Source: org_study_id

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