UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056930 |
|---|---|
| Receipt number | R000065056 |
| Scientific Title | Effects of Ultrasonic-Containing Ambient Sounds on Subjective Eating Experience |
| Date of disclosure of the study information | 2025/02/04 |
| Last modified on | 2025/02/04 14:45:32 |
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Basic information
Public title
Effects of Ultrasonic-Containing Ambient Sounds on Subjective Eating Experience
Acronym
Ultrasonic study
Scientific Title
Effects of Ultrasonic-Containing Ambient Sounds on Subjective Eating Experience
Scientific Title:Acronym
Ultrasonic study
Region
| Japan |
Condition
Condition
Eating Experience in Healthy Individuals
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study explores the effects of ultrasonic-frequency sound (hypersonic sound) on the eating experience. Specifically, it examines how hypersonic sound influences subjective taste perception and its impact on objective indicators such as blood glucose levels and autonomic nervous system markers, including heart rate variability. Ultimately, the study aims to establish fundamental data necessary for estimating the effect size of hypersonic sound, which will be used to design future validation experiments.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Interstitial glucose concentration
Key secondary outcomes
Subjective taste evaluation
Subjective Hunger/Satiety assessment
Electrocardiogram (ECG)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
This study uses digitally recorded sound sources containing ultrasonic frequencies as ambient sounds. The control sound is the same source without ultrasonic frequencies (44.1kHz sampling). Audio files stored on a computer are played using an application compatible with ultrasonic processing. The output digital data is converted to analog via an amplifier with a built-in DAC and repeatedly played through a speaker system covering a wide frequency range (45-100kHz).
Interventions/Control_2
This study uses digitally recorded sound sources containing ultrasonic frequencies as ambient sounds. The control sound is the same source without ultrasonic frequencies (44.1kHz sampling). Audio files stored on a computer are played using an application compatible with ultrasonic processing. The output digital data is converted to analog via an amplifier with a built-in DAC and repeatedly played through a speaker system covering a wide frequency range (45-100kHz).
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
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
University students
Age 18-22 years
Gender Female
BMI 18.5-24.9
Key exclusion criteria
Individuals currently receiving medical treatment (regardless of diagnosis)
Individuals with a habit of skipping breakfast
Individuals who have taken medication between lunch on the day before the study and the start of the study
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiko |
| Middle name | |
| Last name | Yamada |
Organization
Tokyo Kasei Gakuin University
Division name
Department of Pathophysiology
Zip code
102-8341
Address
22 Sanban-cho, Chiyoda-ku, Tokyo, Japan
TEL
03-3262-2251
yamada.mitsuhiko@kasei-gakuin.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuhiko |
| Middle name | |
| Last name | Yamada |
Organization
Tokyo Kasei Gakuin University
Division name
Department of Pathophysiology
Zip code
102-8341
Address
22 Sanban-cho, Chiyoda-ku, Tokyo, Japan
TEL
03-3262-2251
Homepage URL
yamada.mitsuhiko@kasei-gakuin.ac.jp
Sponsor or person
Institute
Tokyo Kasei Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Kasei Gakuin 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
Tokyo Kasei Gakuin University Ethics Review Committee
Address
22 Sanban-cho, Chiyoda-ku, Tokyo 102-8341, Japan
Tel
03-3262-2251
rec@kasei-gakuin.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
| 2025 | Year | 02 | 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
3
Results
Although not significant, the hypersonic group reported higher taste ratings immediately after eating than the control group. Both groups showed a significant rise in interstitial glucose concentration 45 min post-meal, but at 60 min, the hypersonic group had significantly lower levels. This suggests an earlier glucose decline, possibly due to enhanced insulin secretion. The potential role of parasympathetic activation in this response is particularly intriguing.
Results date posted
| 2025 | Year | 02 | Month | 04 | 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 | 07 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 10 | 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
| 2025 | Year | 02 | Month | 04 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065056
