UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059136 |
|---|---|
| Receipt number | R000067643 |
| Scientific Title | Exploratory study on the effects of verbal encouragement on endogenous biomarkers in healthy adult males |
| Date of disclosure of the study information | 2025/11/22 |
| Last modified on | 2025/10/28 09:10:00 |
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Basic information
Public title
Exploratory study on the effects of verbal encouragement on endogenous biomarkers in healthy adult males
Acronym
Exploratory study on the effects of verbal encouragement on endogenous biomarkers in healthy adult males
Scientific Title
Exploratory study on the effects of verbal encouragement on endogenous biomarkers in healthy adult males
Scientific Title:Acronym
Exploratory study on the effects of verbal encouragement on endogenous biomarkers in healthy adult males
Region
| Japan |
Condition
Condition
Healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effects of verbal encouragement on endogenous biomarkers in healthy adult males
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Primary Outcome Measures
Changes in the following omics profiles based on the presence or absence of verbal encouragement (VE):
- Blood: Proteome, metabolome, microRNA, synchrotron radiation-based particle and elemental analysis
- Feces: Microbiome
- Skin: Gas component profile
2) Safety Evaluation
Frequency of adverse events occurring during the verbal encouragement (VE) intervention period
Key secondary outcomes
1) Secondary Outcome Measures
Changes in psychological questionnaire scores based on the presence or absence of verbal encouragement (VE):
- PANAS, POMS2, SHS, GSES, FRS, Mind-body questionnaire
2) Exploratory Outcome Measures
Changes in cognitive function based on the presence or absence of verbal encouragement (VE)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Presence of verbal encouragement - Washout - Absence of verbal encouragement
Interventions/Control_2
Abesence of verbal encouragement - Washout - Presence of verbal encouragement
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 have given written consent to participate in this study
2) Males aged 30 to 59 when obtaining the consent
3) Individuals who are able to undergo preliminary/follow-up examinations, cognitive test, consume the prescribed food, answer the various questionnaire, have blood draws and stool collections, and skin gas collection according to the schedule requested by the research personnel
4) Individuals who scored between 30 and less than 70 in the standardized score of the behavioral temperament test during preliminary examination
Key exclusion criteria
1) Individuals who were deemed ineligible for this study by the principal investigator based on the results of the preliminary examination
2) Individuals with visual, auditory, or motor impairments that interfere with the administration of cognitive function tests
3) Individuals who currently have or previously had gastrointestinal, cardiovascular, endocrine, inflammatory (immunological), neuropsychiatry, or other diseases; individuals who regularly use drugs to treat diseases and are considered unsuitable to participate in this study by the principal investigator; individuals on antibiotics, anti-inflammatory drugs, anti-allergic drugs, steroids, immunosuppressants, etc.; and individuals with a common cold
4) Individuals with smoking habits
5) Individuals who intend to stay abroad overnight between the prescreening and follow-up examinations
6) Individuals with food allergy
7) Individuals who donated blood within 12 weeks prior to the prescreening examination
8) Individuals who are currently participating in another study or are scheduled to participate in one during the study period
9) Individuals who are estimated inappropriate to this study by principal investigator or study director
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Shoichiro |
| Middle name | |
| Last name | Inoue |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Advanced 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 | 11 | Month | 22 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 21 | 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 | 09 | Month | 19 | Day |
Last modified on
| 2025 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067643
