UMIN-CTR Clinical Trial

Basic information
Public title	Study 2 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function
Acronym	Study 2 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function
Scientific Title	Study 2 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function
Scientific Title:Acronym	Study 2 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study was to investigate the effects of continuous intake of test foods for 12 weeks on cognitive function of Japanese men and women who are aware of decline in cognitive function when they are 50 years of age or older and 69 years of age or younger.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cognitrax,MMSE
Key secondary outcomes	Pittsburgh Sleep Quality Index, Blood BDNF, Blood Abeta (1-40, 1-42, oligomers), Blood sAPP alpha, MicroRNAs

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	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	12-week intake of the test food
Interventions/Control_2	12-week intake of the placebo food
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	69 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Japanese men and women aged 50 to 69 years at the time of informed consent 2) Those who are aware of cognitive decline 3) Persons able to take 3 capsules daily for 12 weeks. 4)Persons with an M MMSE score of 24 or more 5) Non smoker 6) A person who has received sufficient explanation of the purpose and content of the research, is capable of giving informed consent, voluntarily volunteers to participate in the research, and consents to participate in the research in writing.
Key exclusion criteria	1) Subjects who are currently receiving any medications or outpatient treatment. 2) History of liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease Or those with a merger 3) Patients with a history of drug or food allergy 4) People who use health foods and supplements that may affect cognitive function 5) Persons using drugs that may affect cognitive function 6) Persons with extreme skipped eating 7) Excessively irregular lifestyle such as eating or sleeping 8) Patients suspected of having insomnia (insomnia, sleep apnea syndrome, etc.) 9) Persons with a current or past history of psychiatric disorders (depression, etc.) 10) Persons with a current or past history of alcoholism 11) Subjects who have participated in other human clinical studies within the past 3 months or are expected to participate in other human clinical studies during the study period. 12) Persons whose working hours are irregular, such as those who have worked at night. 13) Subjects who are pregnant, breast-feeding, or willing to become pregnant during the study period 14) Persons who are difficult to comply with the records of various surveys 15) Other than the above, the principal investigator judged that the subject was ineligible for the study.
Target sample size	52

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takihara Takanobu
Organization	ITOEN,Ltd.
Division name	Central Research Institute
Zip code
Address	21 Mekami, Makinohara-shi, Shizuoka 421-0516, Japan
TEL	0548-54-1247
Email	t-takihara@itoen.co.jp

Public contact
Name of contact person	1st name Middle name Last name Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code
Address	Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	ITOEN,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 09 Month 07 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	Completed
Date of protocol fixation	2018 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date	2018 Year 09 Month 10 Day
Last follow-up date	2018 Year 12 Month 14 Day
Date of closure to data entry	2018 Year 12 Month 19 Day
Date trial data considered complete	2019 Year 01 Month 18 Day
Date analysis concluded	2019 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date	2018 Year 08 Month 20 Day
Last modified on	2019 Year 01 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038266

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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