UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060195 |
|---|---|
| Receipt number | R000068851 |
| Scientific Title | Study evaluating the effect of galvanic tongue stimulation on taste sensation. -Development of a technology to modulate tastes other than saltiness through electrical stimulation, and evaluation of its effects. - |
| Date of disclosure of the study information | 2025/12/24 |
| Last modified on | 2025/12/24 19:56:52 |
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Basic information
Public title
Study evaluating the effect of galvanic tongue stimulation on taste sensation.
-Development of a technology to modulate tastes other than saltiness through electrical stimulation, and evaluation of its effects. -
Acronym
Study evaluating the effect of galvanic tongue stimulation on taste sensation.
Scientific Title
Study evaluating the effect of galvanic tongue stimulation on taste sensation.
-Development of a technology to modulate tastes other than saltiness through electrical stimulation, and evaluation of its effects. -
Scientific Title:Acronym
Study evaluating the effect of galvanic tongue stimulation on taste sensation.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to demonstrate the effect of galvanic tongue stimulation on taste sensation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intensity of taste, oral, and throat sensations (questionnaire-based evaluation).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food | Other |
Interventions/Control_1
Within 1 day, the study participants consume the test food under conditions where a weak oral electrical stimulation is applied. The study participants consume the test food under conditions where no weak oral electrical stimulation is applied.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy adults aged 18 or older and under 65 at the time of obtaining informed consent.
(2) Individuals who understood the study details and provided written informed consent.
(3) Individuals whose preference for vinegar is not extreme.
Key exclusion criteria
Participants will be excluded based on self report if they meet any of the following criteria.
1. Current or past history of cardiac neurological or cerebrovascular disease.
2. Severe respiratory disease including a diagnosis of respiratory failure.
3. Seizure disorders such as epilepsy.
4. Use of medical devices that may be affected by electric or magnetic fields for example pacemakers.
5. Pregnancy or the possibility of being pregnant.
6. History of skin irritation or rashes caused by alcohol.
7. Allergic conditions including food allergies or metal allergies.
8. Abnormalities such as wounds eczema or swelling on the hands inside the mouth or around the mouth.
9. Taste disorders including reduced taste sensitivity loss of taste or dysgeusia.
10. Individuals who meet the conditions listed in the instruction manual of the electrogustatory device used in this study as do not use or use only after consulting a physician unless a physician has determined that participation is acceptable.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Homei |
| Middle name | |
| Last name | Miyashita |
Organization
Meiji University
Division name
Faculty of Interdisciplinary Mathematical Sciences
Zip code
164-0001
Address
4-21-1, Nakano, Nakano-ku, Tokyo, Japan
TEL
03-5343-834
homei@isc.meiji.ac.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Sato |
Organization
Kirin Holdings Company, Limited
Division name
Health Science Business Department
Zip code
164-0001
Address
Nakano central South, 4-10-2, Nakano, Nakano-ku, Tokyo
TEL
080-2990-3796
Homepage URL
ai_sato@kirin.co.jp
Sponsor or person
Institute
Meiji University
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
Mizkan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Office for Human Research Studies(OHRS), Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818 / +81-3-5841-0818
ethics@m.u-tokyo.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 | 12 | Month | 24 | 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 | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | 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 | 12 | Month | 24 | Day |
Last modified on
| 2025 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068851
