UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033781 |
|---|---|
| Receipt number | R000038534 |
| Scientific Title | An Evaluation Study of Indicators Relating to the Function of the Brain Based on Functionality of Food(Cocoa) |
| Date of disclosure of the study information | 2018/08/20 |
| Last modified on | 2020/08/15 11:06:58 |
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Basic information
Public title
An Evaluation Study of Indicators Relating to the Function of the Brain Based on Functionality of Food(Cocoa)
Acronym
An Evaluation Study of Indicators Relating to the Function of the Brain Based on Functionality of Food(Cocoa)
Scientific Title
An Evaluation Study of Indicators Relating to the Function of the Brain Based on Functionality of Food(Cocoa)
Scientific Title:Acronym
An Evaluation Study of Indicators Relating to the Function of the Brain Based on Functionality of Food(Cocoa)
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare and evaluate brain function related indicators useful for evaluating the functionality of food(Cocoa).
Basic objectives2
Others
Basic objectives -Others
Investigation of indicators related to brain functions
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
No decision
Key secondary outcomes
No decision
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
YES
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
1 cocoa-added drink - Washout period - 1 cocoa-free drink
Interventions/Control_2
1 cocoa-free drink - Washout period - 1 cocoa-added drink
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
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Healthy volunteer
2.Males and females aged between 18 and 29
3.Person who receive adequate explanation for participation in this research and provide written informed consent by their own free will
Key exclusion criteria
1.Person who has a disorder that is an obstacle to this study
2.Other persons who judge that the research director or sharers are inappropriate
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Nishizaki |
Organization
Tokai University School of Medicine
Division name
Dept.of Clinical Health Science
Zip code
259-1193
Address
143 Shimokasuya,Isehara,Kanagawa,Japan
TEL
0463-93-1121
y-nishizaki@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Takashige |
| Middle name | |
| Last name | Oroguchi |
Organization
Tokai University School of Medicine
Division name
Lifecare Center Graduate School of Medicine
Zip code
259-1193
Address
143 Shimokasuya,Isehara,Kanagawa,,Japan
TEL
0463-93-1121
Homepage URL
oroguchi@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Institute of Industrial Science and Technology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research,Tokai University Hospital
Address
143 Shimokasuya,Isehara,Kanagawa 259-1193,Japan
Tel
0463-93-1121
tokai-rinsho@ml.tokai-u.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
東海大学医学部大学院医学研究科ライフケアセンター（神奈川）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 20 | 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
| 2018 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 07 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 07 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 25 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 16 | Day |
Last modified on
| 2020 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038534
