UMIN-CTR Clinical Trial

Basic information
Public title	Examination of influence that intake of test food gives to cognitive function-1
Acronym	Examination of influence that intake of test food gives to cognitive function-1
Scientific Title	Examination of influence that intake of test food gives to cognitive function
Scientific Title:Acronym	Examination of influence that intake of test food gives to 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 on cognitive function of Japanese men and women who are aware of decline in cognitive function when they are 40 years of age or older.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cognitrax Repeatable Battery for the Assessment of Neuropsychological Status
Key secondary outcomes	SF-36 Physical examination hematologic test blood biochemical test Urine analysis Adverse event

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	12-weeks intake of the test food
Interventions/Control_2	12-weeks 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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Japanese male and female aged over 40 at the time of the informed consent. 2)Subject who is aware of cognitive decline. 3)Subject who is able to take the test food daily for 12 weeks. 4)Subject with an MMSE score of 24 or more. 5)Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Key exclusion criteria	1)Subject who is taking medication or under medical treatment. 2)Subject who is under exercise therapy or dietetic therapy. 3)Subject who has an allergy for test food. 4)Subject who has or had a history of either medicine or alcohol dependence syndrome. 5)Subject who has or had a history of mental illness (depression) or sleep disturbance. 6)Subject who is on a night-shift or is a shift worker. 7)Subject whose lifestyle is extremely irregular. 8)Subject who has an unbalanced diet. 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(Icho-ha extract,DHA,EPA,Phosphatidylserine,lecithin etc) that may affect cognitive function. 11)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study. 12)Subject who has blood drawn 200mL within the past 1 months or 400mL within the past 3 months from the day of the consent acquisition. 13)Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 14)Subject who can't keep the daily records. 15)Subject who is judged as an inappropriate candidate according to the screening data. 16)Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Yamatsu
Organization	Pharma Foods International Co., Ltd.
Division name	Development Department
Zip code	615-8245
Address	1-49 Goryo-Ohara, Nishikyo-ku, Kyoto, Japan
TEL	075-394-8605
Email	a-yamatsu@pharmafoods.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Pharma Foods International 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	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 05 Month 17 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	2019 Year 04 Month 12 Day
Date of IRB	2019 Year 04 Month 15 Day
Anticipated trial start date	2019 Year 05 Month 15 Day
Last follow-up date	2019 Year 10 Month 04 Day
Date of closure to data entry	2019 Year 10 Month 08 Day
Date trial data considered complete	2019 Year 10 Month 18 Day
Date analysis concluded	2019 Year 11 Month 29 Day

Other
Other related information	The dose of different from "Examination of influence that intake of test food gives to cognitive function-2".

Management information
Registered date	2019 Year 05 Month 13 Day
Last modified on	2019 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041816