UMIN-CTR Clinical Trial

Basic information
Public title	A study of the effects of test food on cognitive function -A randomized, double-blind, placebo-controlled, parallel study
Acronym	A study of the effects on cognitive function
Scientific Title	A study of the effects of test food on cognitive function -A randomized, double-blind, placebo-controlled, parallel study
Scientific Title:Acronym	A study of the effects on cognitive function
Region	Japan

Condition
Condition	Healthy subjects (including MCI) who are aware of the decline in cognitive function due to aging
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify the effects of test food on cognitive function and bowel movement and Its Safety
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of cognitive function by Cognitrax test at 0 week and at 12 weeks
Key secondary outcomes	Evaluation of bowel movements by Defecation survey form at 0 week and at 12 weeks

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	Treatment
Type of intervention	Food
Interventions/Control_1	Oral intake of the test foods (3 chewable in a day for 12 weeks)
Interventions/Control_2	Oral intake of the placebo foods (3 chewable in a day for 12 weeks)
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Healthy subjects with MMSE results by screening test of 24 points or more(healthy person who feels deterioration of cognitive function due to aging and person with mild cognitive impairment) 2) Healthy adults aged 40 to 75 years old. 3) Gender: No preference 4) Subjects without smoking habits 5) Subjects who do not have a habit of taking a meal containing test foods (dairy products such as milk, yogurt, and cheese) 6)Subjects who do not regularly use supplements and health foods (including lactic acid bacteria and bifidobacteria) 7) Subjects who do not suffer from lifestyle diseases (high blood pressure, diabetes etc.), rheumatism, liver disorders, renal disorders, other chronic diseases 8) Subjects who have no history of treatment of malignant tumor, heart failure, myocardial infarction 9) Subjects who have no history of allergy to test foods / medicines 10) Subjects who do not take medication for Outpatient treatment 11)Subjects who are judged by the investigator to have no problem in conducting the trial based on the results of blood tests. 12) Subjects giving written informed consent
Key exclusion criteria	1) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period 2) Subjects who are participating the other clinical tests. Subjects who participated within 3-month prior to the current study 3) Subjects who do not comply with instructions from the doctor or medical staff 4) Others who have been determined ineligible by investigator
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Naotaka Middle name Last name Hashiya
Organization	Kanyukai clinic
Division name	Head
Zip code	553- 0004
Address	2-12-24 Tamagawa Fukushima-ku,Osaka-shi,Osaka,553-0004,Japan
TEL	06-6444-7788
Email	hashiya@carna-medsalon.jp

Public contact
Name of contact person	1st name Taisuke Middle name Last name Fukaya
Organization	Tashikani Plus Co., Ltd
Division name	CEO
Zip code	530-0041
Address	6F 2-2-27 Tenjinbashi Kita-ku,Osaka-shi,Osaka,530-0041,Japan
TEL	06-6352-6622
Homepage URL
Email	fukaya@tashikani.jp

Sponsor
Institute	Kanyukai clinic
Institute
Department

Funding Source
Organization	non-disclosure
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Japan Food Evidence Association
Address	7F 2-2-27 Tenjinbashi,Kita-ku,Osaka,530-0041,Japan
Tel	06-6352-6622
Email	info@food-evidence.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	2022 Year 04 Month 08 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	Preinitiation
Date of protocol fixation	2022 Year 03 Month 31 Day
Date of IRB	2022 Year 04 Month 05 Day
Anticipated trial start date	2022 Year 05 Month 15 Day
Last follow-up date	2022 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 04 Month 07 Day
Last modified on	2022 Year 04 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054089