UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence on human by ingestion of food ingredients
Title of the study (Brief title)	Food ingredient Human test
Region	Japan

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

Objectives
Narrative objectives1	To inspect the improvement effect of the cognitive function by taking a food ingredient for 4 weeks
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluate cognitive function using Five Cognitive Functions, Standard verbal paired-associate learning test, Benton visual retention test
Key secondary outcomes	Mood scale questionnaire, Indefinite complaint questionnaire

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	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	food ingredient containing supplement 6tablet/day
Interventions/Control_2	Placebo supplements 6tablet/day
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)persons who is 60 years old or older (2)persons who is generally judged as healthy (3)persons who can give voluntary written consent to participate in the present trial
Key exclusion criteria	(1) persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficay with the effect evaluated in this study (2) persons who changed their habitats of supplements whitin 4 weeks. (3) Persons who work in night shift or in day and night shift (4) persons who have been treated their illness or prevention in a clinic at their informed consent (5) persons with their medical histories as follows: serious diseases of Sugar metabolism,lipid metabolism, liver function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system (6) persons with the medical histories of alcoholism or drug dependence (7) persons who might be developed allergic reaction to foods. (8) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study preiod (9) persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device) (10) persons who will not be judged suitable to the participants by the investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	Kuniyoshi Shimizu
Organization	Faculty of Agriculture, Kyushu University
Division name	Laboratory of Systematic Forest and Forest Products Science
Address	6-10-1 Hakozaki, Higashi-ku, Fukuoka, Fukuoka, JAPAN
TEL	092-642-3002
Email	shimizu@agr.kyushu-u.ac.jp

Public contact
Name of contact person	Kuniyoshi Shimizu
Organization	Faculty of Agriculture, Kyushu University
Division name	Laboratory of Systematic Forest and Forest Products Science
Address	6-10-1 Hakozaki, Higashi-ku, Fukuoka, Fukuoka, JAPAN
TEL	092-642-3002
Homepage URL
Email	shimizu@agr.kyushu-u.ac.jp

Sponsor
Institute	Faculty of Agriculture, Kyushu University
Institute
Department

Funding Source
Organization	Kurume Research Park Co.Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Faculty of Humanity-Oriented Science and Engineering, Kindai University
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 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 15 Day
Anticipated trial start date	2016 Year 11 Month 18 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 03 Month 02 Day
Last modified on	2017 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030304