UMIN-CTR Clinical Trial

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

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Hemoglobin oxygenation state in the brain

Key secondary outcomes

-Heart rate
-Blood pressure
-questionnaire, VAS
-Cognitive task performance
-microbiota

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

FANCL Corporation

Institute

Department

Personal name

Organization

FANCL Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

09

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Compare the brain activation and other measures between the task conditions.

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