UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042496 |
|---|---|
| Receipt number | R000048508 |
| Scientific Title | Exploratory observational study on olfactory function and mood state in middle-aged and elderly men and women |
| Date of disclosure of the study information | 2021/11/18 |
| Last modified on | 2025/05/22 15:04:55 |
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Basic information
Public title
Exploratory observational study on olfactory function and mood state
Acronym
Exploratory observational study on olfactory function and mood state
Scientific Title
Exploratory observational study on olfactory function and mood state in middle-aged and elderly men and women
Scientific Title:Acronym
Exploratory observational study on olfactory function and mood state in middle-aged and elderly men and women
Region
| Japan |
Condition
Condition
Female and male adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Explore the relationship between olfactory function and mood state
Basic objectives2
Others
Basic objectives -Others
Explore the relationship between olfactory function and mood state
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Olfactory function test
Mood state
Key secondary outcomes
Autonomic nervous function
Saliva volume
Rate of saliva secretion
Salivary stress markers
Oral dryness survey
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who use Japanese as his/her primary language
Key exclusion criteria
Subjects who
1.are receiving treatment related to allergic rhinitis, and/or are suspected of having it
2.have been diagnosed, or have a history with olfactory dysfunction, and are judged as unsuitable by doctor
3.are smokers, or started smoking cessation within the last 12 months before investigation
Target sample size
360
Research contact person
Name of lead principal investigator
| 1st name | Kuniaki |
| Middle name | |
| Last name | Obara |
Organization
Kirin Holdings Company, Limited
Division name
Kirin Central Research Institute, Research & Development Division
Zip code
236-0004
Address
1-13-5, Fukuura Kanazawa-ku, Yokohama, Japan.
TEL
080-1930-9932
k-obara@kirin.co.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Kitani |
Organization
Hamamatsu City Hall
Division name
Health Promotion Division
Zip code
432-8023
Address
2-11-2, Kamoe, Naka-ku, Hamamatsu, Japan.
TEL
053-453-6125
Homepage URL
kenko@city.Hamamatsu.shizuoka.jp
Sponsor or person
Institute
Kirin Holdings Company, Limited
Institute
Department
Personal name
Funding Source
Organization
Kirin Holdings Company, Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
FANCL CORPORATION
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethical Review Committee of Kirin Holdings Company, Ltd.
Address
Nakano Central Park South, 4-10-2, Nakano, Nakano-ku, Tokyo, Japan
Tel
03-6837-4128
02976_Ni@kirin.co.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
| 2021 | Year | 11 | 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
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigate the relationship between olfactory function (identification / threshold), autonomic function and salivary components, and mood / stress status.
The examination is one time.
Management information
Registered date
| 2020 | Year | 11 | Month | 18 | Day |
Last modified on
| 2025 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048508
