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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042496
Receipt No. 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 2021/02/15

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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
Email 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
Email kenko@city.Hamamatsu.shizuoka.jp

Sponsor
Institute Kirin Holdings Company, Limited
Institute
Department

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
Email 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 Open public recruiting
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
2021 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048508

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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