UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019564 |
|---|---|
| Receipt number | R000022620 |
| Scientific Title | An intervention study of green-tea drinking effects on biomarkers of lifestyle-related diseases |
| Date of disclosure of the study information | 2015/10/30 |
| Last modified on | 2019/11/01 12:27:57 |
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Basic information
Public title
An intervention study of green-tea drinking effects on biomarkers of lifestyle-related diseases
Acronym
Effects of green tea on lifestyle-related disease biomarkers
Scientific Title
An intervention study of green-tea drinking effects on biomarkers of lifestyle-related diseases
Scientific Title:Acronym
Effects of green tea on lifestyle-related disease biomarkers
Region
| Japan |
Condition
Condition
allergic reaction
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of green tea on the biomarkers of inflammation and antibodies against chemical substance such as TDI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TDI-specific IgG antibody(6 months after intervention)
Key secondary outcomes
total (non-specific) IgG, IgE
specific IgG against chemical agents (Bisphenol A diglycidyl ether, phthalic anhydride, p-phenylenediamine, formaldehyde, glutaraldehyde, acrylamide, ethylenediamine, Hexamethylene diisocyanate, methyl methacrylate, trimellitic anhydride, glycidyl methacrylate)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Equal to or more than 6 cups of green tea per day (approximately 10 g green tea), for 6 months
Interventions/Control_2
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
volunteers aged 20-75 years old
Key exclusion criteria
1. individuals with a history of heart failure or cardiac infarction
2. individuals with disease(s) of upper-gastrointestinal tract such as gastric ulcer
3. pregnant women or women with intending to become pregnant, and lactating women
4. individuals judged by the doctor to be unsuitable
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Chihaya |
| Middle name | |
| Last name | Koriyama |
Organization
Kagoshima University
Division name
Graduate School of Medical and Dental Sciences, Dept. of Epidemiology and Preventive Medicine
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
099-275-5298
fiy@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Chihaya |
| Middle name | |
| Last name | Koriyama |
Organization
Kagoshima University
Division name
Graduate School of Medical and Dental Sciences, Dept. of Epidemiology and Preventive Medicine
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
099-275-5298
Homepage URL
fiy@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Shibushi Research Council for Functional Capability of Green Tea
Institute
Department
Personal name
Funding Source
Organization
To measure outcomes: University of Occupational and Environmental Health(PI: Mayumi Tsuji)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Occupational and Environmental Health
Name of secondary funder(s)
To conduct intervention study by green-tea drinking: Shibushi City
IRB Contact (For public release)
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
Tel
099-275-6091
isgskkrs@kuas.kagoshima-u.ac.jp
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
| 2015 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 29 | Day |
Last modified on
| 2019 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022620
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
