UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041239 |
|---|---|
| Receipt number | R000047092 |
| Scientific Title | A Study of the influence of test food on Office Workers |
| Date of disclosure of the study information | 2020/07/31 |
| Last modified on | 2021/01/28 11:22:35 |
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Basic information
Public title
A Study of the influence of test food on Office Workers
Acronym
A Study of the influence of test food on Office Workers
Scientific Title
A Study of the influence of test food on Office Workers
Scientific Title:Acronym
A Study of the influence of test food on Office Workers
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the effects of legume based foods on cognitive function and blood sugar
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Condition of cognitive function(shown by Memory Performance Index (MPI) score)
Key secondary outcomes
Blood glucose level, Incremental area under the blood glucose response curve (IAUC), Area under the curve(AUC), Susceptibility score measured by electroencephalography, Operating effectiveness, and Questionnaire
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Control foods (7 times ingestion) - Test foods (7 times ingestion)
Interventions/Control_2
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females aged between 20 and 60
(2) Company employees who usually work in an office
(3) Those who understand the contents of the test and obtain consent
Key exclusion criteria
(1) Those with a significant medical history (including receiving medical treatment) or mental illness
(2) Those who are judged by the responsible investigator to be inappropriate for participation in the study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yasue |
| Middle name | |
| Last name | Mitsukura |
Organization
Faculty of Science and Technology, Keio University
Division name
Department of System Design Engineering
Zip code
223-8522
Address
2-6-1 Hiyoshi, Kouhoku-ku, Yokohama-Shi, Kanagawa, Japan
TEL
045-566-1718
mitsukura@keio.jp
Public contact
Name of contact person
| 1st name | Joto |
| Middle name | |
| Last name | Yoshimoto |
Organization
Mizkan Holdings Co., Ltd.
Division name
Central Research Institute
Zip code
475-8585
Address
2-6 Nakamura-Cho, Handa-Shi, Aichi, Japan
TEL
0569-24-5139
Homepage URL
yoshimoto_jyoutou@mizkan.co.jp
Sponsor or person
Institute
Faculty of Science and Technology, Keio University
Institute
Department
Personal name
Funding Source
Organization
Mizkan Holdings Co., Ltd.
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
Dept of Technology, Keio univ
Address
3-14-1 hiyoshi, yokohama2238522, Japan
Tel
045-566-1455
ecc-jimu@adst.keio.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 | 07 | Month | 31 | 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
| 2021 | Year | 01 | Month | 28 | Day |
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
| 2020 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | 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 | 07 | Month | 29 | Day |
Last modified on
| 2021 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047092
