UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029245 |
|---|---|
| Receipt number | 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 14:01:39 |
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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
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
kao1512@fancl.co.jp
Sponsor or person
Institute
FANCL Research Institute
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033429
