UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054830 |
|---|---|
| Receipt number | R000062486 |
| Scientific Title | Effects of tray color on feeding and swallowing |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/01/06 17:41:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of tray color on feeding and swallowing
Acronym
Effects of tray color on feeding and swallowing
Scientific Title
Effects of tray color on feeding and swallowing
Scientific Title:Acronym
Effects of tray color on feeding and swallowing
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study is to determine whether different colors of trays used during meals affect feeding and swallowing functions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
amount of saliva secretion
Key secondary outcomes
questionnaire
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
| Other |
Interventions/Control_1
Methods for collecting and measuring saliva
The procedure for visually presenting food forms and measuring saliva is as follows.
1. Place uniform-sized medical absorbent cotton in a paper cup and measure its weight using an electronic balance.
2. Gargle with water from a 10cc cup for 10 seconds.
3. Place medical absorbent cotton under the tongue.
4. Look at the front wall (white) for 1 minute.
5. Spit out all of the medical absorbent cotton and saliva remaining in the mouth into the paper cup.
6. Place absorbent cotton under the tongue again and look at a photograph for 1 minute.
7. After the visual stimulation with the photograph, spit out all of the medical absorbent cotton and saliva remaining in the mouth into the paper cup.
8. Measure the weight of the paper cup after the visual stimulation with the photograph.
9. Subtract the weight before stimulation from the total weight after stimulation, and calculate the amount of saliva.
How to conduct a questionnaire
After measuring the amount of saliva secreted for each tray color, a survey was conducted regarding the tray color using a Likert scale.
Survey items:
"What did you think of the taste of this dysphagia food?"
"Did it look tasty?"
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults with documented consent
Key exclusion criteria
1) Persons with a diagnosis of dysphagia
2) Persons with anatomical (static) disabilities to feeding and swallowing disorders
3) Persons of childbearing potential, or who are pregnant or breastfeeding
4) Those who experience nausea, pain, or other discomfort from tooth or tongue stimulation
5) Those who wear dentures.
6) Patients who have dementia or have communication difficulties and have difficulty communicating.
7) Those who are objectively judged to lack the ability to give informed consent.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | MEGUMI |
| Middle name | |
| Last name | MIYAMOTO |
Organization
Kumamoto Health Science University
Division name
Faculty of Health Science Department of Rehabilitation Division of Speech-Language-Hearing Therapy
Zip code
861-5598
Address
325 Izumimachi,Kita-ku,Kumamoto
TEL
096-275-2212
meg-mya@kumamoto-hsu.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Nagano |
Organization
Kumamoto Health Science University
Division name
Planning and Personnel Department
Zip code
861-5598
Address
325 Izumimachi,Kita-ku,Kumamoto
TEL
096-275-2111
Homepage URL
kikaku@kuamoto-hsu.ac.jp
Sponsor or person
Institute
Kumamoto Health Science University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Health Science University
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
Kumamoto Health Science University Life Science Ethical Review Board
Address
325 Izumimachi,Kita-ku,Kumamoto
Tel
0962752111
kikaku@kumamoto-hsu.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
| 2024 | Year | 07 | 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
25
Results
In this study, we investigated changes in saliva secretion and appetite caused by visual stimulation.
The following results were obtained from measuring changes in salivary secretion before and after visual stimulation and from questionnaire responses.
1. There was a significant difference in saliva secretion between the red and blue trays.
2. Regarding appetite and taste, there was a significant difference between the blue tray and each tray (red, yellow, white).
It was recognized.
Results date posted
| 2025 | Year | 01 | Month | 06 | Day |
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
| 2024 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 07 | Month | 01 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062486
