Diabetes MellitusPhase 2/3NCT02147041
The Effect of Extract of Green Tea on Obese Women and Obese Related Hormone Peptides
A Phase 2/3 study testing EGCG(Epigallocatechin Gallate) in people with Diabetes Mellitus and Hyperlipidemia, run by Taipei City Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Diabetes Mellitus, Hyperlipidemia
- What is being tested?
- EGCG(Epigallocatechin Gallate)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2012to Aug 2014
- Phase
- Phase 2/3
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Extract of Green Tea on Obese Women Obese Related Hormone Peptides
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.
Read the detailed description
Obesity has become a noticeable and worldwide public health problem recently. According to the WHO survey in 2005, 1.6 billion and 400 million adults were found overweight and obese, respectively. In Taiwan, there are more than 30% found overweight in the national survey in 2009. Compare with the ones done in 1999 and 2005, a rising trend of the prevalence of obesity is found. Furthermore, the incidence and prevalence of obesity are also increasing worldwide, especially in the developing and newly industrialized nations. In addition, obesity is related to some chronic diseases, like diabetes mellitus, hyperlipidemia and cardiovascular diseases, which are major lethal health concerns in Taiwan and many developing countries. Taken together, obesity emerges as an important issue lately. The aim of the study is to evaluate the therapeutic effect and safety of green tea extract on demographic characteristics and obesity-related hormone peptide of obese women and to establish an obesity Traditional Chinese Medicine (TCM) syndromes questionnaire, which will undergo well assessing of reliability and validity. Second, we intent to utilize the TCM syndromes and Quality of Life (SF-12, WHO) questionnaire to 200 obesity women for the correlation analysis of TCM syndromes, obesity related hormone peptides and quality of life. The results of this study are expected to assess the effect and safety of green tea extract on obese women and improve the scientific diagnosis of TCM with a quantitative measurement by this questionnaire.
- Conditions
- Diabetes Mellitus, Hyperlipidemia
- Being tested
- EGCG(Epigallocatechin Gallate), Placebo
- Keywords
- diabetes mellitus, hyperlipidemia, green tea, epigallocatechin gallate
- Medical subject headings
- Diabetes Mellitus, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGCG(Epigallocatechin Gallate)Drug
Also called EGCG-Epigallocatechin Gallate, green tea extract, cellulose-cellulose
500mg, three times a day, duration:12 weeks
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| EGCG(Epigallocatechin Gallate) | Experimental | EGCG(Epigallocatechin Gallate)(500 mg, three times a day, 12 weeks) Receives: Drug: EGCG(Epigallocatechin Gallate) |
| placebo | Placebo comparator | cellulose (500mg, three times a day, 12 weeks) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite of anthropometric measures
composite include body weight, waist circumference, hip circumference
Measured: compare between the beginning of the study and after 12 weeks of treatment.
Secondary outcomes (4)
Hormone peptide change
hormone peptides such as leptin、adiponectin、ghrelin、fasting insulin resistance、APOB、APOA1
Measured: compared between the beginning of the study and after 12 weeks of treatment
biochemical characteristic change
blood sugar, creatinine, aminotransferases aspartate, aminotransferases alanine, uric acid and
Measured: compare between the beginning of the study and after 12 weeks of treatment.
traditional chinese medicine syndrome classification
Use questionaire to classify traditional chinese medicine syndrome in obese women
Measured: compare between the beginning of the study and after 12 weeks of treatment.
Quality of life evaluation
(1)12-item Short-Form Health Survey (2)WHOQoL-BREF
Measured: compare between the beginning of the study and after 12 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startMay 2012
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Collaborators
- National Yang Ming Chiao Tung University
- Responsible party
- Principal investigator, Chung-Hua Hsu, Taipei City Hospital
- Investigators
- Chung-Hua Hsu, PHD, Study chair, Taipei medical hospital, Linsen Chinese Medicine branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147041
- Sponsor's protocol ID
- 100XDAA00110
- Other IDs
- 100XDAA00110
- Status last verified
- May 2014
- First submitted
- 20 Jan 2014
- Last updated
- 26 May 2014
- 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 18468736Chen 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.
PubMed 26093535
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Extract of Green Tea on Obese Women Obese Related Hormone Peptides
- ClinicalTrials.gov ID
- NCT02147041
- Acronym / sponsor ID
- 100XDAA00110
- Conditions
- Diabetes Mellitus, Hyperlipidemia
- Keywords
- diabetes mellitus, hyperlipidemia, green tea, epigallocatechin gallate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Taipei City HospitalOther government
- Collaborators
- National Yang Ming Chiao Tung University
- Study start
- May 2012
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 26 May 2014 (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 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.
Detailed description
Obesity has become a noticeable and worldwide public health problem recently. According to the WHO survey in 2005, 1.6 billion and 400 million adults were found overweight and obese, respectively. In Taiwan, there are more than 30% found overweight in the national survey in 2009. Compare with the ones done in 1999 and 2005, a rising trend of the prevalence of obesity is found. Furthermore, the incidence and prevalence of obesity are also increasing worldwide, especially in the developing and newly industrialized nations. In addition, obesity is related to some chronic diseases, like diabetes mellitus, hyperlipidemia and cardiovascular diseases, which are major lethal health concerns in Taiwan and many developing countries. Taken together, obesity emerges as an important issue lately. The aim of the study is to evaluate the therapeutic effect and safety of green tea extract on demographic characteristics and obesity-related hormone peptide of obese women and to establish an obesity Traditional Chinese Medicine (TCM) syndromes questionnaire, which will undergo well assessing of reliability and validity. Second, we intent to utilize the TCM syndromes and Quality of Life (SF-12, WHO) questionnaire to 200 obesity women for the correlation analysis of TCM syndromes, obesity related hormone peptides and quality of life. The results of this study are expected to assess the effect and safety of green tea extract on obese women and improve the scientific diagnosis of TCM with a quantitative measurement by this questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EGCG(Epigallocatechin Gallate) | Experimental | Drug: EGCG(Epigallocatechin Gallate)EGCG(Epigallocatechin Gallate)(500 mg, three times a day, 12 weeks) |
| placebo | Placebo comparator | Drug: Placebocellulose (500mg, three times a day, 12 weeks) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- GPT > 80 U/L, serum creatinine > 2.0 mg/dl
- breast feeding or pregnancy
- heart failure
- acute myocardial infarction
- Stroke
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 |
|---|---|---|
| EGCG(Epigallocatechin Gallate)Also: EGCG-Epigallocatechin Gallate, green tea extract, cellulose-cellulose500mg, three times a day, duration:12 weeks | Drug | EGCG(Epigallocatechin Gallate) |
| Placebo | Drug | placebo |
Primary outcome
composite of anthropometric measures
Time frame: compare between the beginning of the study and after 12 weeks of treatment.
composite include body weight, waist circumference, hip circumference
4 secondary outcomes
Hormone peptide change
Time frame: compared between the beginning of the study and after 12 weeks of treatment
biochemical characteristic change
Time frame: compare between the beginning of the study and after 12 weeks of treatment.
traditional chinese medicine syndrome classification
Time frame: compare between the beginning of the study and after 12 weeks of treatment.
Quality of life evaluation
Time frame: compare between the beginning of the study and after 12 weeks of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
- Results publication: 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.
- Derived from this study: PubMed 26093535Chen 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.
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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, PHD study chair
Taipei medical hospital, Linsen Chinese Medicine branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing EGCG(Epigallocatechin Gallate) in people with Diabetes Mellitus and Hyperlipidemia, 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 May 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
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?
composite of anthropometric measures (time frame: compare between the beginning of the study and after 12 weeks of treatment.). 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 NCT02147041, which also lists 2 linked publications.
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 26 May 2014.