UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062820 |
|---|---|
| Receipt number | R000071917 |
| Scientific Title | Effects of visual and auditory feedback during eating on chewing behavior in older adults |
| Date of disclosure of the study information | 2026/09/04 |
| Last modified on | 2026/09/04 13:11:40 |
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Basic information
Public title
A study of how visual and auditory information during eating affects chewing and food texture perception in older adults
Acronym
VAFC Study
Scientific Title
Effects of visual and auditory feedback during eating on chewing behavior in older adults
Scientific Title:Acronym
VAFC Study
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the immediate effects of visual information and chewing-synchronized auditory feedback on chewing behavior, perceived food texture, and eating experience in community-dwelling older adults aged 65 years or older. In addition, associations between individual responses to visual and auditory feedback and oral function, frailty, muscle strength, and muscle mass will be explored.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of chewing cycles.
Surface electromyographic activity of the masseter muscle will be recorded during each food intake trial, and the number of chewing cycles will be calculated from the EMG signal. Three trials will be performed under each condition, and the mean value will be used as the representative value for comparison among the four experimental conditions.
Key secondary outcomes
Integrated masseter EMG (iEMG), root mean square (RMS) of masseter EMG activity, chewing rhythm, and chewing duration will be assessed during each food intake trial. The mean of three trials in each condition will be used as the representative value.
Subjective food texture and eating experience, including perceived hardness, chewiness, texture pleasantness, sense of eating, palatability, enjoyment, satisfaction, desire to eat more, and discomfort with the presented information, will be assessed immediately after each condition.
Oral frailty status, maximum tongue pressure, grip strength, frailty status, body composition, and skeletal muscle mass index (SMI) will be assessed once on the study day, and their associations with individual responses to visual and auditory feedback will be explored.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
No-presentation condition.
Participants will consume approximately 4.0 g of texture-modified food per trial without visual information or pseudo-chewing sound. Three trials will be performed under this condition. The order of the four conditions will be randomized for each participant, with a rest period of 1 to 2 minutes between conditions.
Interventions/Control_2
Visual-information condition.
While consuming approximately 4.0 g of texture-modified food per trial, participants will view an image of the corresponding regular-texture food on a tablet device. No pseudo-chewing sound will be presented. Three trials will be performed under this condition.
Interventions/Control_3
Chewing-synchronized auditory-feedback condition.
While consuming approximately 4.0 g of texture-modified food per trial, chewing timing will be detected from surface electromyographic activity of the masseter muscle, and a pseudo-chewing sound will be presented in synchrony with chewing. No visual food information will be presented. Three trials will be performed under this condition.
Interventions/Control_4
Combined visual and auditory feedback condition.
While consuming approximately 4.0 g of texture-modified food per trial, participants will view an image of the corresponding regular-texture food on a tablet device, and a pseudo-chewing sound will be presented in synchrony with chewing detected from masseter surface electromyographic activity. Three trials will be performed under this condition.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Community-dwelling older adults aged 65 years or older.
Individuals who routinely consume food orally.
Individuals who are able to chew and swallow food independently.
Individuals who are able to consume the test food used in this study.
Individuals who understand the study explanation and provide written informed consent.
Individuals who are able to perceive the visual and auditory information used in the study, with corrective devices such as glasses or hearing aids if necessary.
Key exclusion criteria
Individuals who routinely require texture-modified diets or professional management for eating or swallowing.
Individuals judged unable to safely consume the test food because of frequent coughing, choking, or similar problems during meals.
Individuals with a food allergy to the test food.
Individuals who have been instructed by a physician or other healthcare professional to restrict consumption of the test food or salt intake.
Individuals who have difficulty performing repeated chewing because of temporomandibular joint pain, oral pain, or other conditions.
Individuals in whom surface electrodes cannot be applied to the masseter region because of skin disorders or other conditions.
Individuals judged by the principal investigator to be unsuitable for safe participation in the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Tashiro |
Organization
Kobe Gakuin University
Division name
Faculty of Rehabilitation, Department of Occupational Therapy
Zip code
651-2180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe, Hyogo 651-2180, Japan
TEL
078-974-5403
tashiro@reha.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Tashiro |
Organization
Kobe Gakuin University
Division name
Faculty of Rehabilitation, Department of Occupational Therapy
Zip code
651-2180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe, Hyogo 651-2180, Japan
TEL
078-974-5403
Homepage URL
tashiro@reha.kobegakuin.ac.jp
Sponsor or person
Institute
Kobe Gakuin University
Institute
Department
Personal name
Daisuke Tashiro
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee for Research Involving Human Participants, Faculty of Rehabilitation, Kobe Gakuin University
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe, Hyogo 651-2180, Japan
Tel
078-974-1551
ethic@reha.kobegakuin.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
神戸学院大学（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 04 | 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
| 2026 | Year | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | 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 | 09 | Month | 04 | Day |
Last modified on
| 2026 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071917
