UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033671 |
|---|---|
| Receipt number | R000038390 |
| Scientific Title | A study of biological factors relating to olfactory sense |
| Date of disclosure of the study information | 2018/08/17 |
| Last modified on | 2026/04/10 09:16:04 |
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Basic information
Public title
A study of biological factors relating to olfactory sense
Acronym
Biological factors relating to olfactory sense
Scientific Title
A study of biological factors relating to olfactory sense
Scientific Title:Acronym
Biological factors relating to olfactory sense
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the biological factors relating to olfactory sense
Basic objectives2
Others
Basic objectives -Others
Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of molecules in biological samples, measurement of olfactory sensitivity, assessment of odor quality, analysis of their correlations
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Sniffing odor A -> Sniffing odor C -> Sniffing odor B. On another day, sniffing odor D and E -> Sniffing odor H and I -> Sniffing odor F and G.
Interventions/Control_2
Sniffing odor C -> Sniffing odor B -> Sniffing odor A. On another day, sniffing odor F and G -> Sniffing odor D and E -> Sniffing odor H and I.
Interventions/Control_3
Sniffing odor B -> Sniffing odor A -> Sniffing odor C. On another day, sniffing odor H and I -> Sniffing odor F and G -> Sniffing odor D and E.
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Healthy males and females
-Subjects with no subjective symptoms of olfactory dysfunction
-Subjects who can visit specified location in Tokyo at specified time
Key exclusion criteria
-Subjects with feeling rejection of inserting tweezers to nasal cavity
-Subjects with allergic to lidocaine
-Subjects with feeling rejection of anesthesia with lidocaine
-Subjects with feeling rejection of temporary pain and discomfort in nasal cavity
-Subjects with feeling rejection of sniffing uncomfortable odors
-Subjects who or whose families work for toiletries, cosmetics, eyeglasses, contact lens, pharmaceuticals, medical supplies, research, advertising, and media company, or medical services
-The pregnant and potentially pregnant, subjects in nursing
-Subjects with disease in nose
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Sakamoto |
Organization
Kao Corporation
Division name
Kansei Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7683
sakamoto.takashi@kao.com
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Shirai |
Organization
Kao Corporation
Division name
Kansei Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7682
Homepage URL
shirai.tomohiro@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Edogawa Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9220
uesaka.toshio@kao.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
花王株式会社（栃木県）
株式会社リサーチ・アンド・ディベロップメント（東京都）
社会福祉法人仁生社江戸川病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 17 | Day |
Related information
URL releasing protocol
https://www.nature.com/articles/s41598-023-27937-1
Publication of results
Unpublished
Result
URL related to results and publications
https://www.nature.com/articles/s41598-023-27937-1
Number of participants that the trial has enrolled
30
Results
Olfactory mucus was collected, and odor perception was evaluated. A significant negative correlation was found between age and the amount of olfactory mucus, demonstrating for the first time that olfactory mucus secretion decreases with aging. In addition, both age and olfactory mucus volume showed significant correlations with mean odor intensity ratings, suggesting that reduced olfactory mucus secretion contributes to age-related declines in perceived odor intensity.
Results date posted
| 2026 | Year | 04 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy male and female aged 20-59 years
Participant flow
Recruitment, informed consent, and study execution
Adverse events
None
Outcome measures
Analysis of associations between biological sample characteristics and sensory evaluation results
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 07 | Day |
Last modified on
| 2026 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038390
