UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045217 |
|---|---|
| Receipt number | R000051605 |
| Scientific Title | Study on effects of mixed fermented tea leave powder made from unripe orange fruits and green tea leaves on cognitive functions |
| Date of disclosure of the study information | 2021/08/22 |
| Last modified on | 2022/12/13 13:14:18 |
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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 cognitive functions
Acronym
Effects of fermented tea leaf powder made from unripe orange fruits and green tea leave powder on cognitive function
Scientific Title
Study on effects of mixed fermented tea leave powder made from unripe orange fruits and green tea leaves on cognitive functions
Scientific Title:Acronym
Effects of fermented tea leave powder made from unripe orange fruits and green tea leaves on cognitive function
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effects of feeding fermented tea powder on the improvement of cognitive functions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
multiple tests of cognitive functions
Key secondary outcomes
a blood pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
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 twelve weeks.
Interventions/Control_2
The subjects ingested the active meal for twelve 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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy male and female between 60 and 89 years old
Subjects who feel the decline in memory
Individuals who refrain from binge eating
Individuals who understand the purpose and contents of the experiment
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
Pregnant women, or women with intending to become pregnant, and lactating woman
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
katanaka@sun.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Ito |
Organization
Univercity of Nagasaki
Division name
Regional Partner Center
Zip code
8512195
Address
1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195
TEL
0958135216
Homepage URL
katanaka@sun.ac.jp
Sponsor or person
Institute
Univercity of Nagasaki
Institute
Department
Personal name
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
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
| 2021 | Year | 08 | Month | 22 | 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
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 22 | Day |
Last modified on
| 2022 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051605
