UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041919 |
|---|---|
| Receipt number | R000047743 |
| Scientific Title | Survey of the effects of food intake on cognitive function and brain activity in human |
| Date of disclosure of the study information | 2020/09/28 |
| Last modified on | 2021/03/30 11:01:49 |
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Basic information
Public title
Survey of the effects of food intake on cognitive function and brain activity in human
Acronym
Survey of the effects of food intake on cognitive function and brain activity in human
Scientific Title
Survey of the effects of food intake on cognitive function and brain activity in human
Scientific Title:Acronym
Survey of the effects of food intake on cognitive function and brain activity in human
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of test food intake on cognitive function and brain activity by measureing cerebral blood flow during rest and cognitive tasks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cerebral blood flow
(before intake/after intake)
Key secondary outcomes
- Results of cognitive tasks
- Questionnaires
(before intake/after intake)
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
Polyphenol intake(50mg/day as anthocyanins, single intake)
Interventions/Control_2
placebo intake(same appearance as test diets, single intake)
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Individuals aged from 20 to 59 years, when giving the informed consent.
2)Individuals giving the written informed consent.
Key exclusion criteria
1)Individuals who declare the allergy symptoms against test diets.
2)Individuals who have anamnesis of cranial nerve disease.
3)Individuals who have anamnesis of the autonomic nervous system.
4)Individuals who have mental symptoms,or who have been diagnosed as mental disorder.
5)Individuals who are being treated with hormone, or who have been diagnosed as menopausal symptoms.
6)Individuals who can't perform the study because it's olfactory impairment.
7)Individuals who regularly take drugs or health foods affecting cognitive functions.
8)Individuals who regularly take drugs of health foods affecting autonomic nervous system.
9)Individuals who is not suitable for subjects by pre-test questionnaire.
10)Individuals who are planned to participate in other clinical study.
11)Individuals who are pregnant or breastfeeding during the study.
12)Individuals who sometimes have irregular lifestyles during the study.
13)Individuals who are judged as unsuitable for the study by the investigator for other reason.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Shoji |
Organization
NeU Co., Ltd.
Division name
Brain Science Consultation Business Unit
Zip code
101-0048
Address
Niikura building 5F, 2-2, Kandatsukasa-cho, Chiyoda-ku, Tokyo
TEL
03-6260-9050
masanori.shoji@neu-brains.com
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Shoji |
Organization
NeU Co., Ltd.
Division name
Brain Science Consultation Business Unit
Zip code
101-0048
Address
Niikura building 5F, 2-2, Kandatsukasa-cho, Chiyoda-ku, Tokyo
TEL
03-6260-9050
Homepage URL
masanori.shoji@neu-brains.com
Sponsor or person
Institute
NeU Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Food Materia Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Institute of Human Engineering for Quality Life
Address
6-611, Osaka-ekimae 4th building 16F, 1-11-4-1600, Umeda, Kita-ku, Osaka
Tel
06-6346-9912
hql-rinri-j@hql.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
E20-6-1
Org. issuing International ID_1
Research Institute of Human Engineering for Quality Life
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 | 28 | 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
24
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
| 2020 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 11 | Month | 19 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 28 | Day |
Last modified on
| 2021 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047743
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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