ObesityPhase 3NCT00383058
The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial
A Phase 3 study testing the extract of green tea in people with Obesity, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to examine whether the extract of the green tea is effective on obese women. Read more about this study
- Who is it for?
- Ages 16 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- the extract of green tea
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2006to Jun 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 16-60 years old female
- BMI>27㎞/m2
- Signed informed consent
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine whether the extract of the green tea is effective on obese women.
Read the 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.
- Conditions
- Obesity
- Being tested
- the extract of green tea
- Keywords
- obesity, green tea
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the extract of green teaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
(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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2006 (estimated)
- Study startSep 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Collaborators
- National Science and Technology Council, Taiwan, Taipei Hospital, Taiwan
- Investigators
- Chung-Hua Hsu, MD, PhD, Study director, Chinese Medicine Dep, Taipei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383058
- Sponsor's protocol ID
- TH-Greentea-06-01
- Other IDs
- NSC-95-2320-B-192-001
- Status last verified
- Aug 2009
- First submitted
- 29 Sep 2006
- Last updated
- 1 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18468736
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Extract of Green Tea on Obese Women: a Randomized Double Blindness Clinical Trial
- ClinicalTrials.gov ID
- NCT00383058
- Acronym / sponsor ID
- TH-Greentea-06-01
- Conditions
- Obesity
- Keywords
- obesity, green tea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Taipei City HospitalOther government
- Collaborators
- National Science and Technology Council, Taiwan, Taipei Hospital, Taiwan
- Study start
- Sep 2006
- Study completion
- Jun 2007 (actual)
- First posted
- 2 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 16 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 16-60 years old female
- BMI>27㎞/m2
- Signed informed consent
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the extract of green tea | Drug | – |
Primary outcome
(Percent) reduction of body mass index and body weight
2 secondary outcomes
(Percent) reduction of: Glucose, cholesterol,LDL, HDL and triglyceride
leptin, adiponectin and ghrelin comparisons and analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2009.
- Derived from this study: PubMed 18468736Hsu 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.
- related researchLink provided by the sponsor.
- related researchLink provided by the sponsor.
- related studyLink provided by the sponsor.
- studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chung-Hua Hsu, MD, PhD study director
Chinese Medicine Dep, Taipei Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing the extract of green tea in people with Obesity, run by Taipei City Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Percent) reduction of body mass index and body weight. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00383058, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2009.