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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029245
Receipt No. R000033429
Scientific Title Effect of the supplement on prefrontal cortex activity and mental stress during 2-back task -randomized placebo- controlled double blind cross over study
Date of disclosure of the study information 2017/09/22
Last modified on 2018/03/23

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Basic information
Public title Effect of the supplement on prefrontal cortex activity and mental stress during 2-back task
-randomized placebo- controlled double blind cross over study
Acronym Effect of the supplement on prefrontal cortex activity and mental stress
Scientific Title Effect of the supplement on prefrontal cortex activity and mental stress during 2-back task
-randomized placebo- controlled double blind cross over study
Scientific Title:Acronym Effect of the supplement on prefrontal cortex activity and mental stress
Region
Japan

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

Objectives
Narrative objectives1 To investigate the effect of the supplement on brain activity and mental stress.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes -Brain blood flow
-Event-related potential
-Electrodermal activity
Key secondary outcomes -Behavioral data
-State-Trait Anxiety Inventory for Adults (Japanese version) results
-Short form of the Profile of Mood States (Japanese version) results

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 test food: 15 days
Interventions/Control_2 control food (placebo): 15 days
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria -Individual that is over 49 years old at the time of informed consent is taken.
-Male and Female
HDS-R score above 20 and BDI-II below 17
-Right handed
-Who agreed to participate in the study.
Key exclusion criteria -Smoker
-Who is using the heart pacemaker
-Who has records of any of the below: autonomic nervous system disease (autonomic imbalance, Meniere syndrome), brain disease, depression, bipolar depression and mood disorder
-Who is taking medicine, Chinese medicine or supplements for brain function or brain blood flow improvement
-Who has dermatosis on head, or who may be allergic to the gel if applied on head (for attaching electrodes)
-Who is allergic to soybean
-Who has records of any of the below:
cerebral hemorrhage, subarachnoid hemorrhage, cardiac hypertrophy, cardiac decompensation, ischemic heart disease, nephrosclerosis, Aortic dissection, brain infarction
-Who had brain damage and hospitalized or had an operation within the past 10 years.
-High blood pressure, hyperlipidemia, diabetes, hepatopathy, kidney disease, malignant tumor
-Who is participating other studies
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihisa Abe
Organization FANCL Corporation
Division name Innovation Research Center, FANCL Research Institute
Zip code
Address 12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL 045-820-3891
Email ay0272@fancl.co.jp

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

Sponsor
Institute FANCL Research Institute
Institute
Department

Funding Source
Organization FANCL Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 09 Month 22 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 Completed
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 22 Day
Last modified on
2018 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033429

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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