UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000742 |
|---|---|
| Receipt number | R000000894 |
| Scientific Title | Effects of green tea catechin consumption on plasma adiponectin levels: a randomized controlled trial. |
| Date of disclosure of the study information | 2007/06/22 |
| Last modified on | 2012/02/20 12:35:34 |
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Basic information
Public title
Effects of green tea catechin consumption on plasma adiponectin levels: a randomized controlled trial.
Acronym
Green tea catechin consumption and plasma adiponectin levels.
Scientific Title
Effects of green tea catechin consumption on plasma adiponectin levels: a randomized controlled trial.
Scientific Title:Acronym
Green tea catechin consumption and plasma adiponectin levels.
Region
| Japan |
Condition
Condition
Men and women who wish to improve their lifestyle aged 20 to 79 years without history of cancer, myocardial infarction, cerebrovascular disease, and renal disease.
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of green tea catechin consumption on plasma adiponectin levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma diponectin levels.
Key secondary outcomes
High-sensitive C-reactive protein,
total cholesterol, triglyceride,
HDL cholesterol, LDL cholesterol,
aspartate aminotransferase,
alanine aminotransferase,
gamma-glutamyl transpeptidase,
blood glucose, blood pressure, waist, and body mass index.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
High tea catechin concentration group (400mg/day ):
Study participants drink green tea with high tea catechin concentration during nine weeks after quitted drinking of green tea during one week.
Interventions/Control_2
Low tea catechin concentration group (100mg/day ):
Study participants drink green tea with low tea catechin concentration during nine weeks after quitted drinking of green tea during one week.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons who participate the lifestyle improvement program and persons who do not participate.
Men and women aged 20 to 79 years.
Key exclusion criteria
Persons with history of cancer, myocardial infarction, cerebrovascular disease, or renal disease.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Kuriyama |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Public Health
Zip code
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8123
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Kuriyama |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Public Health
Zip code
Address
2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL
022-717-8123
Homepage URL
kuriyama-thk@umin.ac.jp
Sponsor or person
Institute
Division of Epidemiology, Department of Public Health and Forensic Medicine, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Exploratory Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2007 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 06 | Month | 18 | Day |
Last modified on
| 2012 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000894
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
