UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054594 |
|---|---|
| Receipt number | R000062369 |
| Scientific Title | Emotional Assessment Method Building Test |
| Date of disclosure of the study information | 2024/06/06 |
| Last modified on | 2025/12/09 11:31:32 |
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Basic information
Public title
Emotional Assessment Method Building Test
Acronym
Emotional Assessment Method Building Test
Scientific Title
Emotional Assessment Method Building Test
Scientific Title:Acronym
Emotional Assessment Method Building Test
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to establish a method by which emotions can be evaluated with greater precision by confirming the correlation between existing evaluation methods and a questionnaire originally created by the test sponsor.
Basic objectives2
Others
Basic objectives -Others
Establishment of evaluation method
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire test (2 types of surveys)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of test food 1.
Interventions/Control_2
Intake of test food 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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Men and women between the ages of 20 and 50 at the time of obtaining consent
(2) Persons who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the content well, and are able to give their consent through electromagnetic informed consent.
Key exclusion criteria
(1) Who have any relevant allergy to the test food
(2) Pregnant, lactating, or intending to become pregnant during the study period
(3) Any other person who is determined to be ineligible by the sponsor.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Motoyuki |
| Middle name | |
| Last name | Tagashira |
Organization
Asahi Group Food Ltd.
Division name
Research and Development Division
Zip code
302-0106
Address
Midori 1-1-21, Moriya, Ibaraki
TEL
0570-005-112
motoyuki.tagashira@asahi-gf.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Mori |
Organization
Macromill, Inc.
Division name
Clinical Research Unit, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo Japan
TEL
03-6716-0700
Homepage URL
yuk_mori@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Food Ltd.
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
Institutional review board of Tsukiji Futaba Clinic
Address
Hosokawa Tsukiji Bild. 6th Floor, Tsukiji 1-9-9, Cyuou-ku Tokyo
Tel
03-6226-5812
info@hikobae.net
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
株式会社マクロミル
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 06 | 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
| 2024 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 06 | Day |
Last modified on
| 2025 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062369
