UMIN-CTR Clinical Trial

Basic information
Public title	Study to examine the effect of continuous test food intake on cognitive function -a pre-test-
Acronym	Study to examine the effect of continuous test food intake on cognitive function -a pre-test-
Scientific Title	Study to examine the effect of continuous test food intake on cognitive function -a pre-test-
Scientific Title:Acronym	Study to examine the effect of continuous test food intake on cognitive function -a pre-test-
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety and effect of continuous intake of test food on cognitive function in male and female with cognitive decline between the ages of 60 and 80.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MMSE
Key secondary outcomes	Cognitive function test (eye gaze test), BDNF, IGF-1, IGFBP-3, questionnaire (VAS, QOL)

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	Take 1 packet of test food daily with water after breakfast for 12 weeks
Interventions/Control_2	Take 1 packet of placebo food daily with water after breakfast 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	60 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1. Aged 60 to 80 years old at the time of informed consent. 2. Japanese male and female 3. Those who have subjective symptoms of cognitive decline and are judged by the investigators to have no problem participating in the study 4. Those who can input their own data into the electronic diary 5. Those who can provide written consent
Key exclusion criteria	1. receiving any types of medicines and/or Chinese medical treatment (Abortive use is acceptable) 2. current or history of serious diseases such as liver, kidney, heart, respiratory organs, endocrinology, and metabolic diseases 3. possible allergic symptoms to the test food 4. score of 23 or less on the Cognitive Function Test (MMSE) 5. experience of taking a neuropsychological test at a hospital, etc. 6. taking health foods (foods or supplements for the purpose of maintaining or recovering health) 7. current or history of drug and/or food allergies 8. participation in another clinical trial within one month before providing consent, participating currently or planning to participate 9. excessive consumption of alcohol (alcohol equivalent 60g or more / day) 10. excessive smoking habits (21 or more cigarettes / day) 11. judged by the investigator to be unsuitable for participating in this study
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yoshie Middle name Last name Tokuta
Organization	JELLICE CO., LTD.
Division name	Produvtion & Development group Technical center
Zip code	985-0833
Address	4-4-1 Sakae Tagajo-city Miyagi
TEL	022-361-8821
Email	y.tokuta@jellice.com

Public contact
Name of contact person	1st name Hirokuni Middle name Last name Kayama
Organization	imeQ RD inc.
Division name	Sales department
Zip code	104-0061
Address	6-2-1 Ginza Chuo-ku Tokyo
TEL	03-6704-5968
Homepage URL
Email	h-kayama@imeqrd.co.jp

Sponsor
Institute	imeQ RD inc.
Institute
Department

Funding Source
Organization	JELLICE 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	Suda Clinic institutional review board
Address	2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel	03-3207-8161
Email	suda-clinic_irb@imeq.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	2021 Year 02 Month 13 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	2020 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date	2021 Year 02 Month 14 Day
Last follow-up date	2021 Year 06 Month 09 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 02 Month 04 Day
Last modified on	2021 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049350

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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