UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination on an effect of improving cognitive function by intake of a test food product
Title of the study (Brief title)	Examination on an effect of improving cognitive function by intake of a test food product
Region	Japan

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

Objectives
Narrative objectives1	To examine an influence of a test food product on cognitive function in Japanese males and females aged 50 and over, below 70 who are aware of a decline in the cognitive function, and assign them to take the test food product for 12 weeks on a continuous basis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cognitrax,MMSE
Key secondary outcomes	Hematologic test, blood biochemical test, vital signs

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.Age: 50 and over, below 70 2.Sex: Males and females with Japanese nationality 3.Those who are aware of a decline in cognitive function 4.Those who can take 9 capsules a day for 12 weeks on a continuous basis 5.MMSE score of 22 or higher 6.Non-smoker
Key exclusion criteria	1.Currently in treatment with medication or seeing a doctor for treatment 2.Previous history of hepatic disorder or severe disorder related to kidney, endocrine, cardiovascular system, gastro-intestine, lung, blood, or metabolism, or currently presence of complications 3.Previous history of drug allergy or food allergy 4.Regular intake of a food product or supplements with a possible influence on cognitive function 5.Regular intake of drug with a possible influence on cognitive function 6.Extreme faddiness 7.Extremely irregular lifestyle such as a dietary pattern and a sleeping pattern 8.Suspicion of insomnia 9.Presence or previous history of mental disorder (depression, etc.) 10.Presence or previous history of alcoholism 11.Current participation in another clinical trial or participation in another clinical trial within the last three months 12.Irregular work hours such as working on night shift 13.Determined by the investigator to be unsuitable for enrollment in this study
Target sample size	62

Research contact person
Name of lead principal investigator	Takihara Takanobu
Organization	ITO EN, Ltd.
Division name	Central Research Institute
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	Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Homepage URL
Email	ochitani@huma-c.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	ITO EN,LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2017 Year 12 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 12 Day
Anticipated trial start date	2017 Year 09 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 14 Day
Last modified on	2018 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033318