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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033781
Receipt No. 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 2019/02/25

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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
Middle name
Last name Yasuhiro Nishizaki
Organization Tokai University School of Medicine
Division name Dept.of Clinical Health Science
Zip code
Address 143 Shimokasuya,Isehara,Kanagawa 259-1193,Japan
TEL 0463-93-1121
Email y-nishizaki@tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashige Oroguchi
Organization Tokai University School of Medicine
Division name Lifecare Center Graduate School of Medicine
Zip code
Address 143 Shimokasuya,Isehara,Kanagawa 259-1193,Japan
TEL 0463-93-1121
Homepage URL
Email oroguchi@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai University
Institute
Department

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
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 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
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
2019 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038534

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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