UMIN-CTR Clinical Trial

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
Email	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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051605