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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036331
Receipt No. R000041249
Scientific Title Tea Leaf Food-study
Date of disclosure of the study information 2019/03/28
Last modified on 2019/03/15

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Basic information
Public title Study of tea leaf food on the avoidance
of functional brain aging
Acronym Study of tea leaf food
Scientific Title Tea Leaf Food-study
Scientific Title:Acronym TLF-study
Region
Japan

Condition
Condition Elderly person
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The avoidance of cognitive declines
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The score of neuropsychiatric test evaluating age-related cogntive declines
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Tea Leaf Food A (14g) x 2 per day
for 12 weeks
Interventions/Control_2 Tea Leaf Food B (14g) x 2 per day
for 12 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
60 years-old <=
Age-upper limit
84 years-old >=
Gender Male and Female
Key inclusion criteria Elderly person
Key exclusion criteria Dementia patients
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Tatsuhiro
Middle name
Last name Hisatsune
Organization The University of Tokyo
Division name GSFS
Zip code 277-8562
Address Kashiwanoha 5-1-5, Kashiwa, Chiba
TEL 04-7136-3632
Email hisatsune@edu.k.u-tokyo.ac.jp

Public contact
Name of contact person
1st name Tatsuhiro
Middle name
Last name Hisatsune
Organization The University of Tokyo
Division name GSFS
Zip code 277-8562
Address Kashiwanoha 5-1-5, Kashiwa, Chiba
TEL 04-7136-3632
Homepage URL
Email hisatsune@edu.k.u-tokyo.ac.jp

Sponsor
Institute Grant from KAKENHI
Institute
Department

Funding Source
Organization Grant from KAKENHI
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The University of Tokyo, GSFS
Address Kashiwanoha 5-1-5, Kashiwa, Chiba
Tel 04-7136-3632
Email hisatsune@edu.k.u-tokyo.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
2019 Year 03 Month 28 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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 15 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 10 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 28 Day
Last modified on
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041249

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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