UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058181 |
|---|---|
| Receipt number | R000066483 |
| Scientific Title | Exploring the relationship between emotions and omics profiles |
| Date of disclosure of the study information | 2025/06/16 |
| Last modified on | 2025/06/16 09:07:14 |
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Basic information
Public title
Exploring the relationship between emotions and omics profiles
Acronym
Exploring the relationship between emotions and omics profiles
Scientific Title
Exploring the relationship between emotions and omics profiles
Scientific Title:Acronym
Exploring the relationship between emotions and omics profiles
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the relationship between emotional states and omics profiles in 120 healthy adult males.
Basic objectives2
Others
Basic objectives -Others
Cross-sectional study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(exploratory assessment)
Comparison of omics profiles between two groups with different emotional states
･Blood proteomefecal
･Microbiome
･Blood metabolome
･Blood miRNA
･Blood elemental and particle analysis
(Safety evaluation)
Frequency of adverse events occurring on the day of the medical examination
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
1)Individuals who understand the study content and have provided their consent via the consent form on the website
2)Males aged 30 to 59 at the time of consent
3)Individuals who are able to record their web logs, consume prescribed meals, provide blood, urine, and stool samples, and complete questionnaires according to the specified schedule
4)Individuals who have no history of diagnosis or treatment (outpatient visits, medication, counseling, etc.) at a psychiatric or psychosomatic medicine clinic, either currently or in the past
Key exclusion criteria
1)Individuals who were deemed ineligible for this study by the principal investigator based on the results of the medical examination
2)Individuals who are judged to be ineligible by the principal investigator due to having a past or present medical history of gastrointestinal, cardiovascular, endocrine, inflammatory or other disorders and regularly using any medications
3)Individuals who have taken antibiotics within 4 weeks prior to the stool collection
4)Individuals who have undergone surgery, hospitalization, or blood donation within 12 weeks prior to the medical examination
5)Individuals who plan to stay overseas between the time of obtaining consent and the end of the observation period
6)Individuals with food allergy
7)Individuals with smoking habits
8)Individuals who are currently participating in another study or plan to participate during the study period
9)Individuals who are estimated inappropriate to this study by principal investigator or study director
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shoichiro |
| Middle name | |
| Last name | Inoue |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Advanced Science Research Institute for Core Science
Zip code
520-0106
Address
1-11-1 Karasaki, Otsu, Shiga, Japan
TEL
077-519-0111
Inoue.Shoichiro@otsuka.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miyazawa |
Organization
HUMA R&D CORP
Division name
Clinical Development Department
Zip code
108-0023
Address
NAKANO SPRING Bldg 5F, 4-11-17 Shibaura, Minato-ku, Tokyo 108-0023 Japan
TEL
03-3431-1260
Homepage URL
rd@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., 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
Tokyo Shinjuku Clinic Ethical Review Board
Address
5F,SIL Shinjuku-building,2-46-3,Kabukicho,Shinjuku-ku,Tokyo,160-0021,Japan
Tel
03-6709-6071
tokyoshinjuku@taifukukai.jp
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2025 | Year | 06 | Month | 16 | Day |
Last modified on
| 2025 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066483
