UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041134 |
|---|---|
| Receipt number | 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 13:21:54 |
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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
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
kao1512@fancl.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046977
