UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000039206
Receipt No. 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 (Ver. 2)

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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
Email 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
Email toshio.toyama@meiji.com

Sponsor
Institute Meiji Co.,Ltd
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044667