UMIN-CTR Clinical Trial

Basic information
Public title	A verification study for improving cognitive function with consumption of the test food in healthy subjects aged 40 or more
Acronym	A verification study for improving cognitive function with consumption of the test food in healthy subjects aged 40 or more
Scientific Title	A verification study for improving cognitive function with consumption of the test food in healthy subjects aged 40 or more: A randomized double-blind placebo-controlled trial
Scientific Title:Acronym	A verification study for improving cognitive function with consumption of the test food in healthy subjects aged 40 or more
Region	Japan

Condition
Condition	Healthy Japanese subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effects of consumption of the test food on cognitive function in healthy subjects aged 40 or more
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The measured value of the standardized score of visual memory at 12 weeks after consumption (12w)
Key secondary outcomes	1. The amount of change of the standardized score of composite memory between screening (before consumption; Scr) or start intake (0w) and 12w 2. The measured values and amounts of changes from Scr or 0w of the standardized score of other cognitive domains at 12w 3. The measured values and amounts of changes from 0w in each of the following items at 12w: physical component summary (PCS), mental component summary (MCS), role component summary (RCS), physical functioning, role physical, bodily pain, general health, activity, social functioning, role emotional, and mental health, brain derived neurotrophic factor (BDNF), Tumor Necrosis Factor-alpha (TNF-alpha), Interleukin-6 (IL-6), Biological Antioxidant Potential (BAP), d-Reactive Oxygen Metabolites (d-ROM)

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	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Duration: 12 weeks Test food: Food 1 (Low dose) Administration: Take two pieces per day
Interventions/Control_2	Duration: 12 weeks Test food: Food 2 (High dose) Administration: Take two pieces per day
Interventions/Control_3	Duration: 12 weeks Test food: Control food Administration: Take two pieces per day
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 2. Men or women 3. Subjects aged 40 or more 4. Healthy subjects 5. Subjects who are aware of the decline in their memory function 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects whose scoring of Mini Mental State Examinination (MMSE)-J is 24 or more at Scr 8. Subjects who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory 9. Subjects who have a relatively low standardized score in visual memory by Cognitrax at Scr
Key exclusion criteria	Subjects (who) 1.have a history or current history of serious diseases of the heart, liver, kidneys, or digestive organs, or a history of major digestive system surgery such as gastrectomy, gastrointestinal suture, or intestinal resection 2.have a pacemaker or an implantable cardioverter defibrillator 3.are a treatment for chronic diseases 4.have significant abnormalities in blood pressure, physical and/or hematological data 5.have severe anemia 6.are pre- or post-menopausal women with severe physical changes 7.have dementia 8.have mental health issues 9.take medications and supplements 10.take supplements and/or foods related to improving cognitive functions, and/or take blue-backed fish at least 4 times a week 11.use devices, equipment, and applications that may affect cognitive functions at least 4 times a week 12.are allergies (particularly to wheat, eggs, milk, and soy) 13.are smoker 14.are heavy alcohol intake 15.with extremely irregular life rhythms 16.are on a carbohydrate restriction or diet, or who plan diet during the test period 17.have eaten less than one meal per day at least once a week for the past a month 18.may change their lifestyles during the test period 19.can't do the following actions: replace the main meal with test food at any 2 meals, receive the test food twice per week, and/or store test foods in frozen storage 20.are pregnant, breast-feeding, or planning to become pregnant 21.have been enrolled in other clinical trials within the last 4 weeks (wks) before the agreement to participate in this trial or plan to enroll in another clinical trial during trial period or within 4 wks after test period 22.donated blood before consuming the food (whole blood either 400 mL within 16 wks [women] or 12 wks [men], 200 mL within 4 wks [both], or blood components within 2 wks [both]) 23.are judged as ineligible to participate in the study by the physician
Target sample size	21

Research contact person
Name of lead principal investigator	1st name Tsuyoshi Middle name Last name Takara
Organization	Medical Corporation Seishinkai, Takara Clinic
Division name	Director
Zip code	141-0022
Address	9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL	03-5793-3623
Email	t-takara@takara-clinic.com

Public contact
Name of contact person	1st name Naoko Middle name Last name Suzuki
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	Nisshin Seifun Group Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	IRB@takara-clinic.com

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	医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan) 南町医院 (東京都) Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2021 Year 07 Month 20 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	24
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	2021 Year 07 Month 14 Day
Date of IRB	2021 Year 07 Month 14 Day
Anticipated trial start date	2021 Year 07 Month 21 Day
Last follow-up date	2021 Year 12 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 07 Month 20 Day
Last modified on	2022 Year 03 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051309