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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041134
Receipt No. R000046977
Scientific Title Prefrontal Activation during the Cognitive Task in Healthy Participants: -A Near Infrared Spectroscopy (NIRS) Study-
Date of disclosure of the study information 2020/09/03
Last modified on 2020/07/17

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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

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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