UMIN-CTR Clinical Trial

Basic information
Public title	A study of efficacy and safety of long-term intake of the test food on cognitive function
Acronym	A study of efficacy and safety of long-term intake of the test food on cognitive function
Scientific Title	A randomized, double-blind, placebo-controlled parallel study to assess the efficacy and safety of long-term intake of the test food on cognitive function
Scientific Title:Acronym	A study of efficacy and safety of long-term intake of the test food on cognitive function
Region	Japan

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

Objectives
Narrative objectives1	The efficacy and safety of long-term intake of the test food on cognitive function in human.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Cognitive function test (Cognitrax)
Key secondary outcomes	Blood test Urinalysis Physical condition diary

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral intake of the test food (12 weeks)
Interventions/Control_2	Oral intake of the placebo (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	18 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Healthy males and females aged 20 to less than 75 years old. 2) Subjects who are capable of understanding the study, and those who can give written informed consents.
Key exclusion criteria	1) Subjects who are allergic to products related to the test material of this study. 2) Subjects who are addicted to alcohol or has an extremely irregular dietary habit. 3) Subjects who take drugs, quasi-drugs, dietary supplements, health foods or something other which possibly have effects on this study. 4) Subjects who are judged to have dementia, those who are receiving treatment, medication, and lifestyle guidance from a doctor due to dementia, those who have received it in the past. 5) Subjects who are pregnant or breastfeeding, or desires to get pregnant during the study period. 6) Subjects who are judged unsuitable for this study by principal investigator.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Masataka Middle name Last name Saito
Organization	Kagawa Nutrition University
Division name	Laboratory of Food Science and Technology
Zip code	350-0288
Address	3-9-21 Chiyoda, Sakado, Saitama 350-0288 Japan
TEL	049-282-3729
Email	msaito@eiyo.ac.jp

Public contact
Name of contact person	1st name Yuko Middle name Last name Nagata
Organization	Momoya Co., Ltd.
Division name	Research & Development Division
Zip code	344-8522
Address	410 Akanuma, Kasukabe, Saitama 344-8522, Japan
TEL	048-720-8352
Homepage URL
Email	y.nagata@momoya.co.jp

Sponsor
Institute	Momoya Co., Ltd.
Institute
Department

Funding Source
Organization	Momoya Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The Human Research Ethics Committee of Kagawa Nutrition University
Address	3-9-21 Chiyoda, Sakado, Saitama 350-0288 Japan
Tel	049-289-6041
Email	kenshien@eiyo.ac.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	女子栄養大学（埼玉県） Kagawa Nutrition University (Saitama) 株式会社桃屋（埼玉県） Momoya Co., Ltd. (Saitama)

Other administrative information
Date of disclosure of the study information	2022 Year 05 Month 17 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 02 Month 22 Day
Date of IRB
Anticipated trial start date	2022 Year 05 Month 18 Day
Last follow-up date	2023 Year 05 Month 17 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 02 Month 22 Day
Last modified on	2022 Year 02 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053595

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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