UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048066 |
|---|---|
| Receipt number | R000054781 |
| Scientific Title | The effect of the sense of smell on the sense of taste |
| Date of disclosure of the study information | 2022/07/26 |
| Last modified on | 2023/10/13 16:00:35 |
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Basic information
Public title
The effect of the sense of smell on the sense of taste
Acronym
The effect of the sense of smell on the sense of taste
Scientific Title
The effect of the sense of smell on the sense of taste
Scientific Title:Acronym
The effect of the sense of smell on the sense of taste
Region
| Japan |
Condition
Condition
normal health
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine how the identification of 5 basic tastes changes without the sense of smell.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to examine how the identification of 5 basic tastes changes without the sense of smell.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Each correct answer rate of 5 basic tastes
Key secondary outcomes
Each correct answer rate for 5 beverages
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
holding in the mouth each 20 mL of five basic taste aqueous solutions and five beverages, under two conditions with and without the sense of smell
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
| 25 | years-old | > |
Gender
Female
Key inclusion criteria
Students of School of Oral Health and Welfare, Faculty of Dentistry, Tokushima University
Key exclusion criteria
Persons who have difficulty in obtaining a consent form, Persons with rhinitis or mouth ulcer, Those who have a cold, Others who are judged to be inappropriate by the person in charge
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Miwa |
| Middle name | |
| Last name | Matsuyama |
Organization
Graduate School of Biomedical Sciences, Tokushima University
Division name
Department of Oral Health Care and Rehabilitation
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima-shi, Tokushima, JAPAN
TEL
0886339213
miwa.matsuyama@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Miwa |
| Middle name | |
| Last name | Matsuyama |
Organization
Graduate School of Biomedical Sciences, Tokushima University
Division name
Department of Oral Health Care and Rehabilitation
Zip code
770-8504
Address
3-18-15 Kuramoto-cho, Tokushima-shi, Tokushima, JAPAN
TEL
0886339213
Homepage URL
miwa.matsuyama@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Biomedical Sciences, Tokushima University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
2-50-1, Kuramoto-cho, Tokushima-shi, Tokushima, JAPAN
Tel
088-633-7958 (9650)
brinshoshienk@tokushima-u.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
| 2022 | Year | 07 | Month | 26 | Day |
Related information
URL releasing protocol
https://tocms.ait231.tokushima-u.ac.jp/tocms/app_files/20220714151529_1294_1.pdf
Publication of results
Published
Result
URL related to results and publications
https://tocms.ait231.tokushima-u.ac.jp/tocms/end_houkoku.php?id=12347&houkoku_id=10590
Number of participants that the trial has enrolled
14
Results
The results suggested that odorless basic tastes do not lose their taste discriminability when the sense of smell is deprived, and that the taste discriminability of everyday odorous foods and beverages is reduced when the sense of smell is deprived.
Results date posted
| 2023 | Year | 10 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All fourth-year students in the School of Oral Health and Welfare, Faculty of Dentistry, Tokushima University, excluding those with rhinitis or stomatitis and those with the common cold, who gave their consent to participate in the study.
Participant flow
Of the 15 cases of all fourth-year students at the School of Oral Health and Welfare, Faculty of Dentistry, Tokushima University, those with rhinitis or stomatitis and one with the common cold were excluded, and 14 cases of those who gave consent to participate in the study were excluded.
Adverse events
No adverse events
Outcome measures
Number of correct answers and number of incorrect answers
Ability to discriminate taste
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 15 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 06 | Month | 15 | Day |
Last modified on
| 2023 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054781
