UMIN-CTR Clinical Trial

Basic information
Public title	A study for the effect of the food containing egg-derived ingredient on cognitive functions : A randomized, double-blind, placebo controlled trial.
Acronym	To evaluate the effect of food ingredient on cognitive functions.
Scientific Title	To evaluate the effect of food ingredient on cognitive functions.
Scientific Title:Acronym	To evaluate the effect of food ingredient on cognitive functions.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effect of food ingredient on cognitive functions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cognitive function test score * Assessed by Cognitrax * Perform Cognitrax at before consuming and at 6 and 12 weeks after ingestion
Key secondary outcomes	MoCA-J TMT-A,B SF-36v2

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	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of food ingredient(3g/day). Duration:12 weeks. Administration:Take once a day. * If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2	Ingestion of food ingredient(1g/day). Duration:12 weeks. Administration:Take once a day. * If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_3	Ingestion of food ingredient(0.3g/day). Duration:12 weeks. Administration: Take once a day. * If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_4	Ingestion of placebo. Duration:12 weeks. Administration:Take once a day. * If you forget to take the test food, take it as soon as you remember within the day.
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.Males and females from 60 to 80 years of age. 2.Subjects who get 26 or more in score of Mini Mental State Examination-Japanease (MMSE-J) and subjects who get 30 or less in score of Montreal Cognitive Assessment-Japanease (MoCA-J). 3.Subjects who are experiencing memory loss. 4.Subjects who has received sufficient explanation of the purpose and content of the research, is capable of giving informed consent, voluntarily volunteers to participate in the research, and consents to participate in the research in writing.
Key exclusion criteria	1.Subjects who have mental health issues such as depression disorder or other issues and medical history or treatment of cerebrovascular disease. 2.Subjects who get 6 or more in score of The Geriatric Depression Scale-Short Form-Japanese (GDS-S-J). 3.Subjects who take medicines that may affect the central nervous system, except sleeping pills. 4.Subjects who take supplements related to improving cognitive functions. 5.Subjects who have visual impairment or hearing impairment. 6.Subjects who have serious liver, kidney, heart, respiratory, endocrine, or metabolic diseases. 7.Heavy smoker ,drinker of alcohol or subjects with disordered lifestyle. 8.Subjects who are allergic to medicines and/or the test food related products. 9.Subjects who constantly use or who can't restrict use medicines (related to Antipsychotics, anxiolytics, antidepressants, antiparkinson's drugs, antidepressants, antiepileptics, anticoagulants, etc.) having a possibility of affecting test results. 10.Subjects who constantly use or who can't restrict use supplements, vitamins and nutrient (related to blood flow and antioxidant effect) having a possibility of affecting test results. 11.Subjects who are participating the other clinical tests. 12.Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yoshitaka Middle name Last name Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Zip code	1030001
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	1st name Eiji Middle name Last name Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Zip code	1050023
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	Kewpie Corporation
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	Ethical Committee of Nihonbashi Cardiology Clinic
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel	03-6455-0880
Email	niho-jimucho@well-sleep.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	2020 Year 08 Month 28 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	2020 Year 08 Month 06 Day
Date of IRB	2020 Year 08 Month 06 Day
Anticipated trial start date	2020 Year 08 Month 07 Day
Last follow-up date	2021 Year 01 Month 31 Day
Date of closure to data entry	2021 Year 02 Month 17 Day
Date trial data considered complete	2021 Year 02 Month 17 Day
Date analysis concluded	2021 Year 05 Month 14 Day

Other
Other related information

Management information
Registered date	2020 Year 08 Month 26 Day
Last modified on	2021 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047443