UMIN-CTR Clinical Trial

Basic information
Public title	Study 3 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function
Acronym	Study 3 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function
Scientific Title	Study 3 Verifying the Improving Effect of Green Tea Ingredients on Cognitive Function
Scientific Title:Acronym	Study 3 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 Uchida-Klepelin test Brain-derived neurotrophic factor Amyloid-beta (1-40, 1-42) Secreted Amyloid Precursor Protein-alpha Amyloid Precursor Protein 770 MicroRNA

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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	12-week intake of the test food1
Interventions/Control_2	12-week intake of the test food2
Interventions/Control_3	12-week intake of the placebo food
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) Subject who is aware of cognitive decline 3) Subject who is able to take 3 capsules daily for 12 weeks. 4) Subject with an MMSE score of 24 or more 5) Non smoker 6) Subject 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) Subject who is currently receiving any medications or outpatient treatment. 2)Subject who is currently doing exercise or diet under the supervision of a doctor 3)Subject who is may develop allergy due to the test food 4)Subject who is drug dependent, present or dependent on alcohol 5) Subject who is history of psychiatry during hospitalization due to mental disorder (depression etc.) or sleep disorder (insomnia, sleep apnea syndrome etc.) 6)Night shift or shift workers 7) Excessively irregular lifestyle such as eating or sleeping 8) Subject who is extreme skipped eating 9)Subject who is current disease or history of diabetes, liver disease (hepatitis), kidney disease, serious disease such as heart disease, thyroid disease, adrenal disease, other metabolic diseases 10)Subject who is use health foods, supplements, and medicines that may affect cognitive function 11) Subject who is 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)Subject who is carried out blood collection, component blood donation more than 400 mL within 200 mL or 3 months within one month going back from the date of consent acquisition 13) Subject who is pregnant, breast-feeding, or willing to become pregnant during the study period 14)Subject who is difficult to comply with the records of various surveys 15)Subject who is judged to be unsuitable as subject from clinical laboratory test value and measurement value at the time of SCR 16)Other than the above, the principal investigator judged that the subject was ineligible for the study.
Target sample size	51

Research contact person
Name of lead principal investigator	1st name Takanobu Middle name Last name Takihara
Organization	ITOEN,Ltd.
Division name	Central Research Institute
Zip code	421-0516
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 Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014
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

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

IRB Contact (For public release)
Organization	Ethics Committees of Nihonbashi Egawa Clinic
Address	2F Kotobuki Build. 1-27-12 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel	03-5204-0311
Email	jim@medipharma.co.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 04 Month 26 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	51
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	2019 Year 03 Month 08 Day
Date of IRB	2019 Year 03 Month 11 Day
Anticipated trial start date	2019 Year 05 Month 07 Day
Last follow-up date	2019 Year 08 Month 09 Day
Date of closure to data entry	2019 Year 08 Month 21 Day
Date trial data considered complete	2019 Year 09 Month 03 Day
Date analysis concluded	2020 Year 01 Month 16 Day

Other
Other related information

Management information
Registered date	2019 Year 04 Month 23 Day
Last modified on	2020 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041526