UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000052536
Receipt number R000059947
Scientific Title Sensory evaluation of the aroma of fermented products after opening
Date of disclosure of the study information 2023/10/23
Last modified on 2024/04/09 17:20:56

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Basic information

Public title

Sensory evaluation of the aroma of fermented products after opening

Acronym

Sensory evaluation of the aroma of fermented products after opening

Scientific Title

Sensory evaluation of the aroma of fermented products after opening

Scientific Title:Acronym

Sensory evaluation of the aroma of fermented products after opening

Region

Japan


Condition

Condition

Adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Perform an aroma evaluation after opening the fermented product to assess the quality and intensity of the aroma.

Basic objectives2

Others

Basic objectives -Others

To identify differences in aroma perception due to different sniffing methods and changes in perception over time.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Data on aroma intensity and aroma pleasantness/unpleasantness during 10 segments of the breathing phase (inhale and exhale).

Key secondary outcomes



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

Food

Interventions/Control_1

One type of food

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

21 years-old <=

Age-upper limit

59 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Subjects trained in sensory evaluation for this study at the time of consent.
2. Subjects who have been fully informed of the purpose and content of the study, have the capacity to consent, volunteer of their own free will with full knowledge of the content, and give their written consent to participate in the study.

Key exclusion criteria

1. Subjects who do not like samples.
2. Subjects who have food allergies to milk.

Target sample size

10


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

042-632-5824

Email

yoshio.toyama@meiji.com


Public contact

Name of contact person

1st name Takahiro
Middle name
Last name Kikuchi

Organization

Meiji Co., Ltd.

Division name

R&D Division

Zip code

192-0919

Address

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

TEL

042-632-5824

Homepage URL


Email

takahiro.kikuchi.aa@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

2023 Year 10 Month 23 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

11

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

2023 Year 10 Month 12 Day

Date of IRB

2023 Year 10 Month 12 Day

Anticipated trial start date

2023 Year 11 Month 02 Day

Last follow-up date

2024 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2023 Year 12 Month 13 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2023 Year 10 Month 18 Day

Last modified on

2024 Year 04 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059947