UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041239
Receipt No. 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 2020/07/29

* 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 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
Email 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
Email yoshimoto_jyoutou@mizkan.co.jp

Sponsor
Institute Faculty of Science and Technology, Keio University
Institute
Department

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
Email 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
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
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
2020 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047092

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.