UMIN-CTR Clinical Trial

Basic information
Public title	The evaluation test of cognitive function by oral consumption of the food which contain plasmalogen
Acronym	The evaluation test of cognitive function by oral consumption of the food which contain plasmalogen
Scientific Title	The evaluation test of cognitive function by oral consumption of the food which contain plasmalogen
Scientific Title:Acronym	The evaluation test of cognitive function by oral consumption of the food which contain plasmalogen
Region	Japan

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

Objectives
Narrative objectives1	To confirm the improving effect of cognitive function and the change of the concentration of plasmalogen, amyloid beta and BDNF in blood, by 12 weeks consumption of test foods.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Basical 7 tests of the Cognitrax Plasmalogen Amyloid beta BDNF
Key secondary outcomes	High sensitive CRP in blood 8-OHdG in urine The incidence of side effects and adverse events.

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	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake 2 capsules those contain test food 1 after dinner, for 12 weeks.
Interventions/Control_2	Intake 2 capsules those contain test food 2 after dinner, for 12 weeks.
Interventions/Control_3	Intake 2 capsules those contain no test food after dinner, for 12 weeks.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Males and females aged 50 to 79 when informed consent. 2) Subjects who aware that their memory ability reduced compare to own younger age. 3) Subjects giving written informed consent.
Key exclusion criteria	1) Subjects who constantly use oral medicines, functional foods and/or supplements having a possibility of affecting test results. 2) Subjects who have previous and/or current medical history of serious disease such as cerebral infarction, cerebrovascular disease, psychosis, dementia and so on. 3) Subjects who are given continuous treatment by taking medicines. 4) Subjects who excessive alcohol intake. 5) Subjects who's MMSE-J scores are under 26 points. 6) Subjects who have already been done neuropsychological test at clinic. 7) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work. 8) Subjects who have previous medical history of drug and/or food allergy. 9) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests. 10) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study. 11) Males who donated over 400mL blood and/or blood components within the last three month to the current study. 12) Females who donated over 400mL blood and/or blood components within the last four month to the current study. 13) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. 14) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study. 15) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Kotoura
Organization	MARUDAI FOOD CO.,LTD.
Division name	CENTRAL RESEARCH INSTITUTE
Zip code	569-8577
Address	21-3, Midori-Cho, Takatsuki-Shi, Osaka, 569-8577,JAPAN
TEL	072-661-2552
Email	kotoura_satoshi@marudai.co.jp

Public contact
Name of contact person	1st name Kazuyoshi Middle name Last name Shibata
Organization	CPCC Company Limited
Division name	Planning & Sales Department
Zip code	101-0047
Address	4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL	03-5297-3112
Homepage URL
Email	cpcc-contact@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	MARUDAI FOODS 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	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
Tel	03-5297-5548
Email	IRB@cpcc.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	2018 Year 08 Month 11 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	Completed
Date of protocol fixation	2018 Year 01 Month 18 Day
Date of IRB
Anticipated trial start date	2018 Year 03 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 11 Day
Last modified on	2020 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035681