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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046973
Receipt No. R000053595
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
Date of disclosure of the study information 2022/05/17
Last modified on 2022/02/22

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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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