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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039107
Receipt No. R000044440
Scientific Title Evaluation of brain activity change induced by flavanols intake
Date of disclosure of the study information 2020/01/10
Last modified on 2020/07/09

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Basic information
Public title Evaluation of brain activity change induced by functional food intake
Acronym Evaluation of brain activity change induced by functional food intake
Scientific Title Evaluation of brain activity change induced by flavanols intake
Scientific Title:Acronym Evaluation of brain activity change induced by flavanols intake
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In recent years, the effects of flavanol, a kind of polyphenol, contained in chocolate and cocoa on health have been reported. The purpose of this study is to verify the improvement of cognitive function with cocoa flavanol intake by measuring brain function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes - Brain activity signals (oxygenated hemoglobin signal, deoxygenated hemoglobin signal) for cognitive tasks before cocoa intake
- Brain activity signals for cognitive tasks after cocoa ingestion
Key secondary outcomes - Performance (Accuracy and reaction time) for cognitive tasks before cocoa intake
- Performance (Accuracy and reaction time) for cognitive tasks after cocoa 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 YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 placebo, a can, single dose
Interventions/Control_2 cocoa, a can, single dose
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
65 years-old >=
Gender Male and Female
Key inclusion criteria Healthy volunteers, who have a proper circadian rhythm
Key exclusion criteria ・Smokers
・Population with exercise habits more than twice a week
・Population who drunk alcohol during 24 hours before the test
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hiroki
Middle name
Last name Sato
Organization College of Systems Engineering and Science
Shibaura Institute of Technology
Division name Department of Bioscience and Engineering
Zip code 337-8570
Address 307 Fukasaku, Minuma-ku, Saitama-shi, Saitama
TEL 048-720-6016
Email hiroki@shibaura-it.ac.jp

Public contact
Name of contact person
1st name Hiroki
Middle name
Last name Sato
Organization College of Systems Engineering and Science Shibaura Institute of Technology
Division name Department of Bioscience and Engineering
Zip code 337-8570
Address 307 Fukasaku, Minuma-ku, Saitama-shi, Saitama
TEL 048-720-6016
Homepage URL
Email hiroki@shibaura-it.ac.jp

Sponsor
Institute Department of Bioscience and Engineering,
College of Systems Engineering and Science,
Shibaura Institute of Technology
Institute
Department

Funding Source
Organization Shibaura Institute of Technology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor MORINAGA & CO., LTD.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shibaura Institute of Technology, Institutional Review Board for Bioengineering Research
Address 3-7-5 Toyosu, Koto-ku, Tokyo 135-8548
Tel 03-5859-7340
Email ykodama@ow.shibaura-it.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
2020 Year 01 Month 10 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 10
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 Preinitiation
Date of protocol fixation
2019 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2020 Year 01 Month 13 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
2020 Year 01 Month 09 Day
Last modified on
2020 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044440

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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