UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039206 |
|---|---|
| Receipt number | R000044667 |
| Scientific Title | To obtain the physical properties of foods and the information about ingestion function as the indicator of risk factor of miss-swallowing of elderly people through monitoring lunchtime meal by using sensing devices |
| Date of disclosure of the study information | 2020/01/20 |
| Last modified on | 2021/01/29 09:48:12 |
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Basic information
Public title
To obtain the information about meal and ingestion function of elderly people through lunchtime meal
Acronym
To obtain the information about meal and ingestion function of elderly people through lunchtime meal
Scientific Title
To obtain the physical properties of foods and the information about ingestion function as the indicator of risk factor of miss-swallowing of elderly people through monitoring lunchtime meal by using sensing devices
Scientific Title:Acronym
To obtain the physical properties of foods and the information about ingestion function as the indicator of risk factor of miss-swallowing of elderly people through monitoring lunchtime meal by using sensing devices
Region
| Japan |
Condition
Condition
Residents in elderly housing with life support service and daycare service users
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Obtaining information about ingestion function from residents in elderly housing with life support service and daycare service users
Basic objectives2
Others
Basic objectives -Others
Intake behavior and oral processing required for eating each food
To estimate food intake ability of each subject
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Being able to find out useful information for identifying indicator that enable to estimate miss-swallowing risk
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Residents in elderly housing with life support service and/or daycare service users.
Subjects served unmodified food
Key exclusion criteria
Subjects under medical treatment of oromandibular area at screening
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Toyama |
Organization
Meiji Co.,Ltd
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni,Hachiouji,Tokyo 192-0919,JAPAN
TEL
042-632-5824
toshio.toyama@meiji.com
Public contact
Name of contact person
| 1st name | Yoshio |
| Middle name | |
| Last name | Toyama |
Organization
Meiji Co.,Ltd
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni,Hachiouji,Tokyo 192-0919,JAPAN
TEL
042-632-5824
Homepage URL
toshio.toyama@meiji.com
Sponsor or person
Institute
Meiji Co.,Ltd
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Institute of Advanced Industrial Science and Technology(AIST)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji clinical trial review committee
Address
1-29-1 Nanakuni,Hachiouji,Tokyo 192-0919,JAPAN
Tel
042-632-5900
MEIJI.IRB@meiji.com
Secondary IDs
Secondary IDs
YES
Study ID_1
2018-292
Org. issuing International ID_1
National Institute of Advanced Industrial Science and Technology(AIST)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
社会福祉法人 小田原福祉会 潤生園 みんなの家ほりのうち
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | 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
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 | 03 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe the mastication-related muscle activity of elderly residents and day service users.
Management information
Registered date
| 2020 | Year | 01 | Month | 20 | Day |
Last modified on
| 2021 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044667
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
