UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000057458
Receipt number R000065637
Scientific Title Evaluation of the usefulness of panel training using odor presentation equipment
Date of disclosure of the study information 2025/03/31
Last modified on 2025/03/31 12:51:30

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Basic information

Public title

Evaluation of the usefulness of panel training using odor presentation equipment

Acronym

Evaluation of the usefulness of panel training using odor presentation equipment

Scientific Title

Evaluation of the usefulness of panel training using odor presentation equipment

Scientific Title:Acronym

Evaluation of the usefulness of panel training using odor presentation equipment

Region

Japan


Condition

Condition

Adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To confirm the usefulness of panel training using an odor presentation device (NOS-DX1000) by training odor discrimination ability and comparing the difference in discrimination ability before and after training.

Basic objectives2

Others

Basic objectives -Others

evaluate the validity of training methods

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Discrimination power of odor presentation device

Key secondary outcomes

percentage of correct 5-point identification of yogurt


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

smell the odor presented to

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

22 years-old <=

Age-upper limit

60 years-old >

Gender

Male and Female

Key inclusion criteria

1.Full-time employees working at the Meiji Innovation Center
2.Those who have been fully informed about the purpose and content of the study, have the ability to consent, and have fully understood the purpose and content of the study, and have volunteered freely and agreed to participate.

Key exclusion criteria

1.Mean detection threshold of -1 or less in the olfactory ability test
2.Persons who are and may be pregnant
3.Persons who are allergic to milk
4.Persons who are aware of smell disturbance

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yoshio
Middle name
Last name Toyama

Organization

Meiji Co., Ltd.

Division name

R&D Division

Zip code

192-0919

Address

1-29-1 Nanakuni, Hachioji, Tokyo, Japan

TEL

042-632-5864

Email

yoshio.toyama@meiji.com


Public contact

Name of contact person

1st name Mariko
Middle name
Last name Nihei

Organization

Meiji Co., Ltd.

Division name

R&D Division

Zip code

192-0919

Address

1-29-1 Nanakuni, Hachioji, Tokyo, Japan

TEL

042-632-5864

Homepage URL


Email

mariko.nihei@meiji.com


Sponsor or person

Institute

R&D Division, Meiji Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Meiji Institutional Review Board

Address

1-29-1 Nanakuni, Hachioji, Tokyo, Japan

Tel

042-632-5900

Email

MEIJI.IRB@meiji.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

株式会社 明治 明治イノベーションセンター(東京都)
Meiji Innovation center, Meiji Co., Ltd. (Tokyo)


Other administrative information

Date of disclosure of the study information

2025 Year 03 Month 31 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

20

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

2024 Year 08 Month 05 Day

Date of IRB

2024 Year 09 Month 12 Day

Anticipated trial start date

2024 Year 10 Month 01 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2025 Year 03 Month 31 Day

Last modified on

2025 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065637