UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052756 |
|---|---|
| Receipt number | R000060195 |
| Scientific Title | Acceptability Study of Electric Taste Devices |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2023/11/10 13:45:15 |
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Basic information
Public title
Acceptability Study of Electric Taste Devices
Acronym
Acceptability Study of Electric Taste Devices
Scientific Title
Acceptability Study of Electric Taste Devices
Scientific Title:Acronym
Acceptability Study of Electric Taste Devices
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the effects of applying weak transdermal electrical stimulation to saline water and food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Taste intensity, Palatability
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 |
Interventions/Control_1
Intervention period of one day. Under the condition of administering weak transcutaneous electrical stimulation, NaCl aqueous solution and food are consumed. Verify how the presence or absence of electrical stimulation changes the taste and preference of the NaCl aqueous solution and food.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Persons who are 20 years of age or older at the time of obtaining consent
(2) Japanese nationals
(3) Persons who understand the research and give written consent.
Key exclusion criteria
1. have lacerations or other injuries in the oral cavity
2. has a pacemaker, artificial heart lung, or other medical electrical device implanted in your body
3. have any kind of heart disease
4. have any kind of brain disease
5. have a malignant tumor
6. have a cold or other health problems
7. sweating profusely during exercise, etc.
8. having any disease of the tongue or oral cavity
9. has pain caused by electrical stimulation due to cavity filling, dental implant, or orthodontic treatment
10. having seizures due to epilepsy of any degree
11. pregnant or possibly pregnant
12. has a piercing in any part of the face (ear, nose, lip, tongue, etc.) (metal fittings that can be removed immediately may participate if they can be removed at the time of the study)
Target sample size
77
Research contact person
Name of lead principal investigator
| 1st name | Nobuhisa |
| Middle name | |
| Last name | Shimba |
Organization
Ajinomoto Co., Inc.
Division name
R&B Planning Department
Zip code
104-8315
Address
1-15-1 Kyobashi, Chuo-ku, Tokyo
TEL
03-5250-8111
nobuhisa.shimba.q7s@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Matsumoto |
Organization
Ajinomoto Co., Inc.
Division name
R&B Planning Department
Zip code
104-8315
Address
1-15-1 Kyobashi, Chuo-ku, Tokyo
TEL
070-4017-7889
Homepage URL
ryo.matsumoto.zp9@asv.ajinomoto.com
Sponsor or person
Institute
Ajinomoto Co., Inc.
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Tokyo
Name of secondary funder(s)
IRB Contact (For public release)
Organization
AJINOMOTO INSTITUTIONAL REVIEW BOARD
Address
1-15-1 Kyobashi, Chuo-ku, Tokyo
Tel
03-5250-8111
ajinomoto_irb@asv.ajinomoto.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 31 | 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
| 2023 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 02 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 10 | Day |
Last modified on
| 2023 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060195
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
