UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038407 |
|---|---|
| Receipt number | R000043768 |
| Scientific Title | Brain health effect test by continuous intake of high cacao chocolate |
| Date of disclosure of the study information | 2019/10/29 |
| Last modified on | 2020/10/28 19:06:39 |
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Basic information
Public title
Brain health effect test by continuous intake of high cacao chocolate
Acronym
Brain health effect test by cacao chocolate
Scientific Title
Brain health effect test by continuous intake of high cacao chocolate
Scientific Title:Acronym
Brain health effect test by cacao chocolate
Region
| Japan |
Condition
Condition
Healthy adul
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Allocate 100 healthy adults to two groups, the group that randomly ingests the test food and the group that does not ingest, and compare the brain activity after each test food intake.
Basic objectives2
Others
Basic objectives -Others
brain structure
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Structure MRI
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Every day, 25 g of the chocolate in intervention period
Interventions/Control_2
no chocolate
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
| 40 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All subjects voluntarily signed the informed consent after detailed description and understanding of this study
Key exclusion criteria
1) Those who may suffer from allergy by administering cacao, milk or soybean.
2) Those who were included other clinical trials within one month before giving written informed consent, or during this study.
2) Any other reasons unfavorable to participation in this <RI study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasuharu |
| Middle name | |
| Last name | Koike |
Organization
Tokyo Institute of Technology
Division name
IIR
Zip code
226-8503
Address
4259, Nagatsuta-cho midoriku yokohama kanagawa
TEL
045-924-5054
koike@cns.pi.titech.ac.jp
Public contact
Name of contact person
| 1st name | Yasuharu |
| Middle name | |
| Last name | Koike |
Organization
Tokyo Institute of Technology
Division name
IIR
Zip code
226-8503
Address
4259, Nagatsuta-cho midoriku yokohama kanagawa
TEL
045-924-5054
Homepage URL
koike@cns.pi.titech.ac.jp
Sponsor or person
Institute
BHQ
Institute
Department
Personal name
Funding Source
Organization
BHQ
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
Tokyo Institute of Technology
Address
2-12-1, Oookayama, Meguro-ku, Tokyo
Tel
03-5734-3808
hitorinri@jim.titech.ac.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
| 2019 | Year | 10 | Month | 29 | 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
104
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
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 28 | Day |
Last modified on
| 2020 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043768
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
