UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051629 |
|---|---|
| Receipt number | R000058893 |
| Scientific Title | Investigation of the persistence of the effect of taste sensitivity traning |
| Date of disclosure of the study information | 2023/07/18 |
| Last modified on | 2023/07/14 18:45:16 |
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Basic information
Public title
Investigation of the persistence of the effect of taste sensitivity training
Acronym
Investigation of the persistence of the effect of taste sensitivity training
Scientific Title
Investigation of the persistence of the effect of taste sensitivity traning
Scientific Title:Acronym
Investigation of the persistence of the effect of taste sensitivity traning
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In our previous study, we confirmed the effectiveness of taste recall training using the filter paper disc method for the four basic tastes in healthy subjects, but it is not clear how long the effect lasts. In this study, we aim to clarify the duration of the effect and establish a method for taste recall training.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Healthy adults will be randomly assigned to either a 3-day or 5-day taste recall training group. Taste recognition thresholds will be assessed at the beginning and end of training, and then weekly after the end of training until 8 weeks after the end of training to evaluate changes in taste recognition thresholds.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
3 days of taste recall training
Interventions/Control_2
5 days of taste recall training
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults who wished to participate in this study aged 20-64 years with no noted taste disorder
Key exclusion criteria
Healthy adults who don't wished to participate in this study. Healthy adults with taste disorder.
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Ebihara |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Internal Medicine and Rehabilitation Science
Zip code
980-8574
Address
Seiryo-machi 1-1 Aoba-ku Sendai, Miyagi
TEL
0227177353
satoru.ebihara.c4@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Ebihara |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Internal Medicine and Rehabilitation Science
Zip code
980-8575
Address
Seiryo-machi 1-1, Aoba-ku Sendai, Miyagi
TEL
0227177353
Homepage URL
satoru.ebihara.c4@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2023 | Year | 07 | Month | 18 | 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 | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | 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
| 2023 | Year | 07 | Month | 18 | Day |
Last modified on
| 2023 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058893
| Research Plan | |
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| 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 |
