UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053442 |
|---|---|
| Receipt number | R000060984 |
| Scientific Title | Effects of texture properties of semi-solid food on the ease of swallowing. |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2025/07/29 10:50:22 |
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Basic information
Public title
Effects of texture properties of semi-solid food on the ease of swallowing.
Acronym
Effects of texture properties of semi-solid food on the ease of swallowing.
Scientific Title
Effects of texture properties of semi-solid food on the ease of swallowing.
Scientific Title:Acronym
Effects of texture properties of semi-solid food on the ease of swallowing.
Region
| Japan |
Condition
Condition
Men and women over 75 years old
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory evaluation of the ease of swallowing of semi-solid foods with different textures.
Basic objectives2
Others
Basic objectives -Others
Swallowing sound data when ingesting semi-solid liquid foods with different physical properties will be used for analysis. Pattern multiple features extracted from swallowing sound data. Perform cluster analysis using patterned features to evaluate differences and similarities between foods.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Swallowing sound data during semi-solid foods ingestion.
Key secondary outcomes
Compare swallowing sound data, flavor evaluation, and subjective evaluation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Semi-solid liquid food.
Interventions/Control_2
Semi-solid liquid food with physical properties different from intervention 1.
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Men and women aged 75 years or older on the date of consent for this study.
2) Those who have received sufficient explanation about the purpose and content of this study, have the consent ability and fully understandings, and have agreed voluntarily to participate in this study, and consented to participate in writing.
Key exclusion criteria
1) Those who have the following past or current medical history.
Cerebrovascular disease.
History of swallowing-related tumors.
Diseases that affect swallowing function, including neurodegenerative and neuromuscular diseases.
Respiratory disease.
Upper digestive disorders.
Organic diseases of laryngopharyngeal.
2) Subjects who have been diagnosed with a disorder related to eating and swallowing.
3) Subjects who are over 70 years old and also have been diagnosed with pneumonia.
4) Subjects with limited dietary or water intake.
5) Subjects who have no experience with and do not like dry sweets (crackers, cookies, potato chips, rice crackers, etc.)
6) Subjects with milk, wheat and soy allergies.
7) Subjects who need assistance for coming to the facility.
8) Subjects who have difficulty wearing neckbands.
9) Subjects who have difficulty understanding instructions.
10) Any other subject who is judged to be ineligible as a research subject by the research implementation director, research physician, or research representative.
Target sample size
20
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,Hachioji,Tokyo,192-0919,Japan
TEL
042-632-5824
yoshio.toyama@meiji.com
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Hisajima |
Organization
Meiji Co.,Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni,Hachioji,Tokyo,192-0919,Japan
TEL
042-632-5824
Homepage URL
tomoko.hisajima@meiji.com
Sponsor or person
Institute
Meiji Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co.,Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Geriatrics and Gerontology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Meiji institutional Review Board
Address
1-29-1 Nanakuni,Hachioji,Tokyo,192-0919,Japan
Tel
042-632-5900
MEIJI.IRB@meiji.com
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
PLIMES株式会社（茨城県）／PLIMES Co.,Ltd.(Ibaraki)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
No URL
Publication of results
Partially published
Result
URL related to results and publications
No URL
Number of participants that the trial has enrolled
21
Results
Chewing time was significantly longer in P than in P (p=0.030). There was no significant difference in swallowing time per bite, but individual variation was significantly smaller in P than in P (p=0.003).
Results date posted
| 2025 | Year | 07 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
21 healthy adults aged 75 years or older with no underlying disease causing swallowing dysfunction
Participant flow
A total of thirty individuals were recruited in anticipation of withdrawals or dropouts, aiming for twenty study subjects, evenly divided between men and women. Due to scheduling conflicts and other factors, twenty-one potential participants were secured. All of them attended on the day of the study. Twenty individuals were selected as study subjects based on the exclusion criteria. After the study, six individuals were excluded due to incomplete records of study food intake, missing data, incorrect use of equipment, and difficulty interpreting waveforms. Consequently, fourteen individuals, consisting of seven men and seven women with an average age of eighty-one point five seven years and a standard deviation of three point five zero years, were included as analysis subjects.
Adverse events
None
Outcome measures
Oral retention time
Swallowing time
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 25 | Day |
Last modified on
| 2025 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060984
