UMIN-CTR Clinical Trial

Basic information
Public title	Prefrontal Activation during the Cognitive Task in Healthy Participants: -A Near Infrared Spectroscopy (NIRS) Study-
Acronym	Prefrontal Activation during the Cognitive Task in Healthy Participants
Scientific Title	Prefrontal Activation during the Cognitive Task in Healthy Participants: -A Near Infrared Spectroscopy (NIRS) Study-
Scientific Title:Acronym	Prefrontal Activation during the Cognitive Task in Healthy Participants
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effect of the cognitive task on prefrontal activation.
Basic objectives2	Others
Basic objectives -Others	To investigate the brain activation during the cognitive task.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hemoglobin oxygenation state in the brain
Key secondary outcomes	-Heart rate -Blood pressure -questionnaire, VAS -Cognitive task performance -microbiota

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	25 years-old <=
Age-upper limit	46 years-old >
Gender	Male
Key inclusion criteria	1. Males 25 to 45 years of age 2. Daytime workers 3. Right handed
Key exclusion criteria	1.Who have color-vision deficiency, 2.Who have deficiency in visual acuity. 3.Who have deficiency in hearing. 4.Who have MMSE score lower than 25. 5.Who have symptoms of dementia, or were diagnosed as dementia in the past. 6.Who has records of any kind of cerebral nerve disorders. 7.Who have BDI score higher than 13. 8.Who have or had dysregulational problem related to hypothalamic-pituitary-adrenal axis. 9.Who is undergoing hormone- related treatment or diagnosed as menopause. 10.Who have or had anhydrosis. 11.Undergone digestive system surgery. 12.Who have both daytime and nighttime shifts during the study period 13.Vegans or vegetarians, 14.Smoker, or who have quit smoking in the last 12 months. 15.Attended to a stress or emotion related studies in the past 12 months. 16.Undergoing brain related treatment, or prescribed with related medicines. 17.Aware of sleep-related diseases such as sleep apnea, restless legs syndrome, and insomnia. 18.Taking medicines, health foods, foods for specified health uses, foods with nutrient function claims, and foods with functional claims that contain ingredients that may affect the study results, once or more times a week. 19.Who cannot stop taking any of the above food in (18) from 5 days before the day of testing. 20.Who have diarrhea or constipation regularly. 21.Do not have defecation more than 3 times a week. 22.Took antibiotics within 2 months of beginning of the study. 23.Who donated or transfed 200 mL, 400 mL or whole blood within the last 3 months 24.Who have participated in other clinical studies within one month or who are planning to participate other clinical studies during the study period. 25.Who have disease that requires constant medication, or those who have a serious medical history that requires medication . 26.Who are judged to be unsuitable participantbased on the examination results. 27.Who works, or whose family works for a functional food -related company. 28.Who are considered to be unsuitable.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Yui
Organization	FANCL Corporation
Division name	Research Institute
Zip code	244-0806
Address	12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL	045-820-3532
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	1st name Kao Middle name Last name Yamaoka
Organization	FANCL Corporation
Division name	Research Institute
Zip code	2440806
Address	12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL	045-820-3965
Homepage URL
Email	kao1512@fancl.co.jp

Sponsor
Institute	FANCL Corporation
Institute
Department

Funding Source
Organization	FANCL Corporation
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	Japanese Conference of Clinical Reasearch
Address	1-13-23, Minamiikebukuro, Toshima Ku, Tokyo To, 171-0022, Japan
Tel	03-6868-7022
Email	jccr.info@jccr.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

Other administrative information
Date of disclosure of the study information	2020 Year 09 Month 03 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	2020 Year 07 Month 17 Day
Date of IRB	2020 Year 07 Month 17 Day
Anticipated trial start date	2020 Year 09 Month 03 Day
Last follow-up date	2021 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Compare the brain activation and other measures between the task conditions.

Management information
Registered date	2020 Year 07 Month 17 Day
Last modified on	2020 Year 07 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046977