UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039107 |
|---|---|
| Receipt number | 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 | 2022/01/12 17:36:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hiroki@shibaura-it.ac.jp
Sponsor or person
Institute
Department of Bioscience and Engineering,
College of Systems Engineering and Science,
Shibaura Institute of Technology
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 11 | Day |
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
| 2022 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.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 |
