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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048130
Receipt No. R000054542
Scientific Title Study on effects of mixed fermented tea leave powder made from unripe orange fruits and green tea leaves on memory and walking ability
Date of disclosure of the study information 2022/06/24
Last modified on 2022/06/22

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Basic information
Public title Study on effects of mixed fermented tea leave powder made from unripe orange fruits and green tea leaves on memory and walking ability
Acronym Effects of mixed fermented tea leave powder on memory and walking ability
Scientific Title Study on effects of mixed fermented tea leave powder made from unripe orange fruits and green tea leaves on memory and walking ability
Scientific Title:Acronym Effects of mixed fermented tea leave powder on memory and walking ability
Region
Japan

Condition
Condition Dementia
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examine the effects of feeding fermented tea powder on the improvement of memory and walking ability
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Multiple tests of cognitive functions and walking tests
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 The subjects ingested the placebo meal for twenty weeks
Interventions/Control_2 The subjects ingested the active meal for twenty 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
50 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Healthy male and female between 50 and 89 years old
Subjects who feel the decline in memory
Key exclusion criteria Subjects who are diagnosed with dementia
Subjects who has suffered by serious cerebrovascular disease, neurological disorder and visceral diseases
Those who can not stop taking a large amount of green tea or black tea during the test period
Subjects who may have food allergies
Individuals participating or intending to participate in a drug administration test
Subjects who get sick by feeding caffeine
Alcoholics
Individuals can't agree with this study
Individuals judged by the doctor to be unsuitable
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Kazunari
Middle name
Last name Tanaka
Organization Univercity of Nagasaki
Division name Regional Partnership Center
Zip code 8512195
Address 1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL 0958135216
Email katanaka@sun.ac.jp

Public contact
Name of contact person
1st name Kanako
Middle name
Last name Imai
Organization Univercity of Nagasaki
Division name Regional Partnership Center
Zip code 8512195
Address 1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL 0958135216
Homepage URL
Email katanaka@sun.ac.jp

Sponsor
Institute Univercity of Nagasaki
Institute
Department

Funding Source
Organization charle Co.,Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Univercity of Nagasaki
Address 1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
Tel 0958135216
Email katanaka@sun.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
2022 Year 06 Month 24 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 60
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
2022 Year 06 Month 24 Day
Date of IRB
2022 Year 04 Month 10 Day
Anticipated trial start date
2022 Year 06 Month 24 Day
Last follow-up date
2022 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
2022 Year 06 Month 22 Day
Last modified on
2022 Year 06 Month 22 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054542

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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