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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033670
Receipt No. R000038389
Scientific Title A study of relationship between odor perception and the genotype of an olfactory receptor gene
Date of disclosure of the study information 2018/08/20
Last modified on 2019/07/12

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Basic information
Public title A study of relationship between odor perception and the genotype of an olfactory receptor gene
Acronym A study of relationship between odor perception and the genotype of an olfactory receptor gene
Scientific Title A study of relationship between odor perception and the genotype of an olfactory receptor gene
Scientific Title:Acronym A study of relationship between odor perception and the genotype of an olfactory receptor gene
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Oto-rhino-laryngology Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To discover relationship between odor perception and the genotype of an olfactory receptor gene
Basic objectives2 Others
Basic objectives -Others Mechanism analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of odor sensitivity and impression among the three different genotypes of an olfactory receptor gene
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Diagnosis
Type of intervention
Gene
Interventions/Control_1 We are going to select the subjects who have wild-type / wild-type genotype about a certain missense mutation of olfactory receptor gene X and get them evaluate three odors.
Interventions/Control_2 We are going to select the subjects who have wild-type / mutant genotype about a certain missense mutation of olfactory receptor gene X and get them evaluate three odors.
Interventions/Control_3 We are going to select the subjects who have mutant / mutant genotype about a certain missense mutation of olfactory receptor gene X and get them evaluate three odors.
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
59 years-old >=
Gender Male and Female
Key inclusion criteria Subjects who feel themselves normal about odor perception
Key exclusion criteria -Subjects with a chronic disease, and either attending the hospital or taking medicine
-Subjects with odor perception disorder
-Subjects who dislike perfume, or other odor substances
-Subjects who are hypersensitive to chemicals
-Subjects undergoing a hormone replace therapy
-Subjects who are pregnant or likely to be.
-Subjects who are lactating
-Subjects with an infectious disease
-Subjects considered unsuitable to participate in this study by the investigators of this study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoko Saito
Organization Kao Corporation
Division name Kansei Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7683
Email saito.nao@kao.com

Public contact
Name of contact person
1st name
Middle name
Last name Dan Takase
Organization Kao Corporation
Division name Kansei Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7685
Homepage URL
Email takase.dan@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 20 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
2018 Year 07 Month 25 Day
Date of IRB
2018 Year 07 Month 25 Day
Anticipated trial start date
2018 Year 08 Month 21 Day
Last follow-up date
2019 Year 06 Month 30 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
2019 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038389

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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