UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063128 |
|---|---|
| Receipt number | R000072265 |
| Scientific Title | Examination of Mastication/Swallowing Characteristics and Satisfaction During Consumption of Soy-Component Mixed Foods |
| Date of disclosure of the study information | 2026/10/06 |
| Last modified on | 2026/10/06 08:12:56 |
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Basic information
Public title
Examination of Mastication/Swallowing Characteristics and Satisfaction During Consumption of Soy-Component Mixed Foods
Acronym
Examination of Mastication/Swallowing Characteristics and Satisfaction During Consumption of Soy-Component Mixed Foods
Scientific Title
Examination of Mastication/Swallowing Characteristics and Satisfaction During Consumption of Soy-Component Mixed Foods
Scientific Title:Acronym
Examination of Mastication/Swallowing Characteristics and Satisfaction During Consumption of Soy-Component Mixed Foods
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop and evaluate foods that contribute to maintaining mastication and swallowing abilities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electromyographic (EMG) activity, acoustic measurements, facial dynamics, pulse wave, electroencephalogram (EEG)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consume test food and measured electromyographic activity, swallowing sounds, facial expressions, pulse waves, brain waves, and sensory evaluation.
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
No abnormalities in masticatory, swallowing, or gustatory functions.
No history of food allergies (especially to ingredients used in the study).
Key exclusion criteria
Individuals with food allergies (especially to ingredients used in this study).
Individuals with abnormalities in masticatory, swallowing, or taste functions.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Miki |
| Middle name | |
| Last name | Yoshimura |
Organization
University of Hyogo
Division name
School of Human Science and Environment
Zip code
670-0092
Address
1-1-12 Shinzaike-honcho, Himeji, Hyogo
TEL
079-292-1515
miki@shse.u-hyogo.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Yagi |
Organization
University of Hyogo
Division name
Advanced Medical Engineering Research Institute
Zip code
670-0836
Address
3-264 Kamiya-cho, Himeji, Hyogo
TEL
079-280-1327
Homepage URL
naomi@ame.u-hyogo.ac.jp
Sponsor or person
Institute
University of Hyogo
Institute
Department
Personal name
Funding Source
Organization
Hirayama Nippn Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The SHSE (School of Human Science and Environment) Research Ethics Committee of the University of Hyogo
Address
1-1-12 Shinzaike-honcho, Himeji, Hyogo
Tel
079-292-1515
u_hyogo_kankyou@ofc.u-hyogo.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
| 2026 | Year | 10 | Month | 06 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 10 | Month | 01 | Day |
Last modified on
| 2026 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072265
