UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033670
Receipt number 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 2026/04/10 09:34:45

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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 Keiichi
Middle name
Last name Yoshikawa

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

Email

saito.nao@kao.com


Public contact

Name of contact person

1st name Dan
Middle name
Last name Takase

Organization

Kao Corporation

Division name

Kansei Science Research

Zip code

321-3497

Address

2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN

TEL

+81-285-68-7685

Homepage URL


Email

takase.dan@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


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

0356309064

Email

morisaki.naoko@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)


Other administrative information

Date of disclosure of the study information

2018 Year 08 Month 20 Day


Related information

URL releasing protocol

https://www.nature.com/articles/s42003-025-08229-y

Publication of results

Published


Result

URL related to results and publications

https://www.nature.com/articles/s42003-025-08229-y

Number of participants that the trial has enrolled

150

Results

Differences in detection thresholds and perceptual sensitivity to Ambroxan are expected according to OR7A17 genotype, indicating involvement of OR7A17.

Results date posted

2026 Year 04 Month 03 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Participants are healthy Kao employees(men and women aged 20-59)who selfreport normal olfaction; screening:150, secondary trial:60.

Participant flow

Recruitment-consent-saliva-collection (screening: 150)-genotyping-select 60 participants (three groups of 20)-secondary trial- store DNA/information of consenting participants.

Adverse events

None

Outcome measures

-Differences in detection thresholds,perceived intensity, pleasantness, and unpleasantness for each odorant by OR7A17 genotype
-Determination of the OR7A17 genotype.

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

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=R000038389