UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053059 |
|---|---|
| Receipt number | R000060545 |
| Scientific Title | Study on how to drink green tea as a dietary therapy |
| Date of disclosure of the study information | 2023/12/15 |
| Last modified on | 2024/12/11 09:16:20 |
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Basic information
Public title
Study on how to drink green tea as a dietary therapy
Acronym
Study on how to drink green tea as a dietary therapy
Scientific Title
Study on how to drink green tea as a dietary therapy
Scientific Title:Acronym
Study on how to drink green tea as a dietary therapy
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm whether different ways of drinking green tea affect communication, neuropsychological tests, and magnetoencephalography tests.
Basic objectives2
Others
Basic objectives -Others
Quality and quantity of communication
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Quality and quantity of communication
Key secondary outcomes
Correlation analysis between the quality and quantity of communication and neuropsychological test results and magnetoencephalography test results
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Drinking green tea A for 4 weeks
Interventions/Control_2
Drinking green tea B for 4 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Both spouses living together can participate.
2. Both spouses agree to participate.
3. For research purposes, you can drink tea every day in principle.
4. Both spouses are over 50 years old
5. Persons who do not have a history of neurological or psychiatric diseases such as stroke, dementia, or depression.
6. Must be able to visit Kumagaya General Hospital on designated days approximately five times for research purposes.
7. Those who agree to the anonymization and publication of information obtained for research purposes.
Key exclusion criteria
1. Items with metal in the body, such as cochlear implants or pacemakers (because they may interfere with MRI examinations, etc.)
2. Those who have claustrophobia (as it may interfere with MRI examinations, etc.)
3. Any other person who is judged by a doctor or researcher to be unsuitable as a research subject.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshihito |
| Middle name | |
| Last name | Shigihara |
Organization
Kumagaya General Hospital
Division name
MEG Centre
Zip code
360-8567
Address
Nakanishi4-5-1, Kumagaya, Saitama 360-8567, Japan
TEL
048-521-0065
y-shigihara@hokuto7.or.jp
Public contact
Name of contact person
| 1st name | Yoshihito |
| Middle name | |
| Last name | Shigihara |
Organization
Kumagaya General Hospital
Division name
MEG Centre
Zip code
360-8567
Address
Nakanishi4-5-1, Kumagaya, Saitama 360-8567, Japan
TEL
0570-099-080
Homepage URL
meaw.system@gmail.com
Sponsor or person
Institute
Kumagaya General Hospital
Institute
Department
Personal name
Funding Source
Organization
ITO EN, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
ITO EN, Ltd.
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Ethics committee of Kumagaya General Hospital
Address
Nakanishi4-5-1, Kumagaya, Saitama
Tel
0570-099-080
kumasou@kumasou.or.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
熊谷総合病院（埼玉県）／Kumagaya General Hospital (Saitama)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 15 | 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
28
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
| 2023 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
| 2025 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 11 | Day |
Last modified on
| 2024 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060545
