UMIN-CTR Clinical Trial

Basic information
Public title	Survey of the effects of food intake on cognitive function and brain activity in human
Acronym	Survey of the effects of food intake on cognitive function and brain activity in human
Scientific Title	Survey of the effects of food intake on cognitive function and brain activity in human
Scientific Title:Acronym	Survey of the effects of food intake on cognitive function and brain activity in human
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of test food intake on cognitive function and brain activity by measureing cerebral blood flow during rest and cognitive tasks.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	cerebral blood flow (before intake/after intake)
Key secondary outcomes	- Results of cognitive tasks - Questionnaires (before intake/after intake)

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	Polyphenol intake(50mg/day as anthocyanins, single intake)
Interventions/Control_2	placebo intake(same appearance as test diets, single intake)
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	1)Individuals aged from 20 to 59 years, when giving the informed consent. 2)Individuals giving the written informed consent.
Key exclusion criteria	1)Individuals who declare the allergy symptoms against test diets. 2)Individuals who have anamnesis of cranial nerve disease. 3)Individuals who have anamnesis of the autonomic nervous system. 4)Individuals who have mental symptoms,or who have been diagnosed as mental disorder. 5)Individuals who are being treated with hormone, or who have been diagnosed as menopausal symptoms. 6)Individuals who can't perform the study because it's olfactory impairment. 7)Individuals who regularly take drugs or health foods affecting cognitive functions. 8)Individuals who regularly take drugs of health foods affecting autonomic nervous system. 9)Individuals who is not suitable for subjects by pre-test questionnaire. 10)Individuals who are planned to participate in other clinical study. 11)Individuals who are pregnant or breastfeeding during the study. 12)Individuals who sometimes have irregular lifestyles during the study. 13)Individuals who are judged as unsuitable for the study by the investigator for other reason.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Masanori Middle name Last name Shoji
Organization	NeU Co., Ltd.
Division name	Brain Science Consultation Business Unit
Zip code	101-0048
Address	Niikura building 5F, 2-2, Kandatsukasa-cho, Chiyoda-ku, Tokyo
TEL	03-6260-9050
Email	masanori.shoji@neu-brains.com

Public contact
Name of contact person	1st name Masanori Middle name Last name Shoji
Organization	NeU Co., Ltd.
Division name	Brain Science Consultation Business Unit
Zip code	101-0048
Address	Niikura building 5F, 2-2, Kandatsukasa-cho, Chiyoda-ku, Tokyo
TEL	03-6260-9050
Homepage URL
Email	masanori.shoji@neu-brains.com

Sponsor
Institute	NeU Co., Ltd.
Institute
Department

Funding Source
Organization	Meiji Food Materia Co., Ltd.
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Research Institute of Human Engineering for Quality Life
Address	6-611, Osaka-ekimae 4th building 16F, 1-11-4-1600, Umeda, Kita-ku, Osaka
Tel	06-6346-9912
Email	hql-rinri-j@hql.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	E20-6-1
Org. issuing International ID_1	Research Institute of Human Engineering for Quality Life
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 09 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	24
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 19 Day
Date of IRB	2020 Year 09 Month 28 Day
Anticipated trial start date	2020 Year 09 Month 30 Day
Last follow-up date	2020 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete	2020 Year 11 Month 19 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 09 Month 28 Day
Last modified on	2021 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047743