UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059923 |
|---|---|
| Receipt number | R000068512 |
| Scientific Title | Evaluation of the Safety and Usefulness of a Newly Developed Flavored Edible Film for Healthy Older Adults, and Validation of Its Assessment Methods |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/11/29 10:45:57 |
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Basic information
Public title
Study on How an Edible Film Affects Saliva Production in Healthy Older Adults
Acronym
Safety and Evaluation of an Edible Film for Healthy Older Adults
Scientific Title
Evaluation of the Safety and Usefulness of a Newly Developed Flavored Edible Film for Healthy Older Adults, and Validation of Its Assessment Methods
Scientific Title:Acronym
Evaluation of the Safety, Usefulness, and Assessment Methods of an Edible Film in Healthy Older Adults
Region
| Japan |
Condition
Condition
Healthy older adults (no specific disease)
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the safety and usefulness of a newly developed edible film in 15 healthy older adults by confirming whether it can be ingested without causing a significant increase in salivary volume measured with an oral moisture meter, and by determining whether taste stimulation can be perceived through sensory evaluation. In addition, this study aims to examine whether emotional and facial expression changes induced by ingesting the edible film can be detected using an electroencephalogram (EEG) device and a facial expression analyzer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
No significant increase in salivary volume 10 seconds after ingesting the edible film
Key secondary outcomes
Ingestion of the edible film results in the observation of the emotional states Expectant and Impressed in EEG measurements.
Ingestion of the edible film results in the observation of the facial expressions Joy and Surprise in facial expression analysis.
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Edible film: Participants ingest one sheet orally, followed by measurements of salivary volume, taste stimulation response, EEG activity, and facial expression changes.
A total of four edible films will be used. The intervention will be conducted only once during the experimental session
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Individuals aged 65 years or older.
2. Individuals who correctly answered both items on the olfactory nerve test.
3. Individuals without any restriction of mouth opening.
4. Individuals with no olfactory dysfunction.
Key exclusion criteria
1. Individuals with restricted mouth opening.
2. Older adults with structural abnormalities of the oral cavity or upper gastrointestinal tract that make swallowing saliva difficult.
3. Individuals who have symptoms of a cold on the day of the experiment.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kiyoshi |
| Middle name | |
| Last name | HOTTA |
Organization
College of Life and Health Sciences, Chubu University
Division name
Department of Nursing
Zip code
4878501
Address
1200 Matsumoto-cho, Kasugai-shi, Aichi, Japan
TEL
09051022349
k_hotta@isc.chubu.ac.jp
Public contact
Name of contact person
| 1st name | Kiyoshi |
| Middle name | |
| Last name | HOTTA |
Organization
College of Life and Health Sciences, Chubu University
Division name
Department of Nursing
Zip code
4878501
Address
1200 Matsumoto-cho, Kasugai-shi, Aichi, Japan
TEL
09051022349
Homepage URL
k_hotta@fsc.chubu.ac.jp
Sponsor or person
Institute
chubu university
Institute
Department
Personal name
Funding Source
Organization
Another
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Human Environments
Address
3-220 Ebata-cho, Obu-shi, Aichi, Japan
Tel
0562-43-0701
kyoumukauhe.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
人間環境大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 01 | 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
| 2025 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 11 | Month | 29 | Day |
Last modified on
| 2025 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068512
