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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000039097
Receipt No. R000044591
Scientific Title Effects of a Test Food for Cognitive Function
Date of disclosure of the study information 2020/01/21
Last modified on 2020/08/03

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Basic information
Public title Effects of a Test Food for Cognitive Function
Acronym Effects of a Test Food for Cognitive Function
Scientific Title Effects of a Test Food for Cognitive Function
Scientific Title:Acronym Effects of a Test Food for Cognitive Function
Region
Japan

Condition
Condition N/A(healthy adults)
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to examine effects of a test food for cognitive function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Japanese version of the CNS Vital Signs (Cognitrax)
Key secondary outcomes Doctor's questions, blood glucose

Base
Study type Interventional

Study design
Basic design Cross-over
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 Treatment
Type of intervention
Food
Interventions/Control_1 Single oral ingestion of the test food (once)
Interventions/Control_2 Single oral ingestion of the placebo food (once)
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
20 years-old <=
Age-upper limit
40 years-old >
Gender Male and Female
Key inclusion criteria 1)Japanese individuals aged 20-39 years.
2)Individuals who are healthy and are not suffered from a chronic malady.
3)Individuals whose written informed consent has been obtained.
4)Individulals who can visit an inspection facility and be inspected in designated days.
5)Individuals judged appropriate for the study by the principal.
6)Individuals who can draw blood from a fingertip.
Key exclusion criteria 1)Individuals using medical products.
2)Individuals with dementia or sleep disorder.
3)Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung and blood disease.
4)Individuals who contract or have a history of serious gastrointestinal disease.
5)Individuals who have an addiction to alcohol or a mental illness.
6)Individuals who used a drug for treatment of disease in the past 1 month.
7)Individuals with probable seasonal allergy, such as pollinosis, during the test period.(Betulaceae: alder, oba alnus firma, shirakaba, Taxodiaceae: cryptomeria, hinoki cypress, Asteraceae: ragweed, Artemisia vulgaris indica, Gramineae: Dactylis glomerata, Phleum pratense)
8)Individuals who contract or have a history of food allergy.
9)Individuals with serious anemia.
10)Individuals with high blood glucose (fasting blood glucose over 126 mg/dL).
11)Individuals who are a smoker.
12)Females who are or are possibly pregnant, or are lactating.
13)Individuals whose life style will change during the test period.
14)Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
15)Individuals who had a habit to ingest foods claiming to improve cognitive function, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
16)Individuals who had a habit to use drug claiming to improve cognitive function in the past 3 months.
17)Individuals who were hospitalized and received treatment in the past 6 months, or will be hospitalized during the test period.
18)Individuals who participated in other clinical studies in the past 1 months.
19)Individuals judged inappropriate for the study by the principal.
Target sample size 16

Research contact person
Name of lead principal investigator
1st name Minoru
Middle name
Last name Morita
Organization Morinaga & Co.,Ltd
Division name Health Science and Research Center, R&D institute
Zip code 230-8504
Address 2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL 045-571-6140
Email m-morita-je@morinaga.co.jp

Public contact
Name of contact person
1st name Sadao
Middle name
Last name Mori
Organization Morinaga & Co.,Ltd
Division name Health Science and Research Center, R&D institute
Zip code 230-8504
Address 2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL 045-571-6140
Homepage URL
Email s-mori-ab@morinaga.co.jp

Sponsor
Institute MORINAGA & CO., LTD.
Institute
Department

Funding Source
Organization MORINAGA & 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 NPO MINS
Address 401 5-20-9 mita minato-ku Tokyo
Tel 03-6416-1868
Email npo-mins@j-irb.com

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 01 Month 21 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://lifescience.co.jp/yk/yk20/ykj2007.html
Number of participants that the trial has enrolled 16
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 Main results already published
Date of protocol fixation
2019 Year 12 Month 04 Day
Date of IRB
2019 Year 12 Month 19 Day
Anticipated trial start date
2020 Year 01 Month 09 Day
Last follow-up date
2020 Year 02 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 09 Day
Last modified on
2020 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044591

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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