UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036331 |
|---|---|
| Receipt number | R000041249 |
| Scientific Title | Tea Leaf Food-study |
| Date of disclosure of the study information | 2019/03/28 |
| Last modified on | 2023/03/31 10:01:15 |
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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
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
hisatsune@edu.k.u-tokyo.ac.jp
Sponsor or person
Institute
Grant from KAKENHI
Institute
Department
Personal name
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
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
Main results already published
Date of protocol fixation
| 2019 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 01 | Day |
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
| 2023 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041249
