UMIN-CTR Clinical Trial

Basic information
Public title	Effects of a Test Food for Cognitive Function (1)
Acronym	Effects of a Test Food for Cognitive Function (1)
Scientific Title	Effects of a Test Food for Cognitive Function (1)
Scientific Title:Acronym	Effects of a Test Food for Cognitive Function (1)
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 qustions, 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. 3)Individuals with high blood glucose (fasting blood glucose over 100 mg/dL). 4)Individuals who used a drug for treatment of disease in the past 1 month. 5)Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. 6)Individuals who contract or have a history of serious gastrointestinal disease. 7)Individuals with serious anemia. 8)Individuals who contract or have a history of food allergy. (milk, gelatin) 9)Females who are or are possibly pregnant, or are lactating. 10)Individuals who have an addiction to alcohol or a mental illness. 11)Individuals who are a smoker. 12)Individuals whose life style will change during the test period. 13)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) 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 have a habit to use drug claiming to improve cognitive function in the past 3 months. 17)Individuals who conducted hormone replacement therapy in the past 6 months or have a history of conducting hormone replacement therapy. 18)Individuals who were hospitalized and received treatment in the past 6 months, or will be hospitalized during the test period. 19)Individuals who participated in other clinical studies in the past 1 months. 20)Individuals judged inappropriate for the study by the principal.
Target sample size	12

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	Japan Aesthetic Dermatology Symposium
Address	15-1-604,Himonya 5-Chome,Meguro-ku,Tokyo,Japan
Tel	03-3794-1235
Email	info@jp-ads.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	2019 Year 06 Month 20 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	14
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 06 Month 07 Day
Date of IRB	2019 Year 06 Month 05 Day
Anticipated trial start date	2019 Year 06 Month 10 Day
Last follow-up date	2019 Year 07 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2019 Year 05 Month 30 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=R000042044