UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058616 |
|---|---|
| Receipt number | R000067000 |
| Scientific Title | Exploration of the effects of Shinrin-yoku (forest bathing) on health-related behavior and physiological measures |
| Date of disclosure of the study information | 2025/07/28 |
| Last modified on | 2025/07/28 14:42:52 |
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Basic information
Public title
Exploration of the effects of Shinrin-yoku (forest bathing) on health-related behavior and physiological measures
Acronym
Exploration of the effects of Shinrin-yoku (forest bathing) on health-related behavior and physiological measures
Scientific Title
Exploration of the effects of Shinrin-yoku (forest bathing) on health-related behavior and physiological measures
Scientific Title:Acronym
Exploration of the effects of Shinrin-yoku (forest bathing) on health-related behavior and physiological measures
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 forest bathing on health-related behavior and physiological measures in healthy adult men
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(exploratory assessment)
Compare sleep measures on the day of intervention (Day 2) and health-related behavior and physiological measures on the day after intervention (Day 3) in the forest-bathing intervention period and the city-walking intervention period
･Sleep parameters : Sleep duration, Sleep score
･Health-related behaviors : Step count, Distance traveled, METs, Calories burned
･Physiological indicators : Heart rate, Heart rate variability, Blood oxygen saturation
Compare plasma markers in the forest-bathing intervention period and the city-walking intervention period
･Adrenaline, Noradrenaline
･Cortisol
Compare research questionnaire in the forest-bathing intervention period and the city-walking intervention period
･POMS2, PANAS, FRS (Web-based diary)
･SHS, GSES
Compare omics profiles in the forest-bathing intervention period and the city-walking intervention period
･Blood proteome
･Fecal microbiome
･Blood metabolome
･Blood miRNA
･Blood elemental and particle analysis
(Safety evaluation)
Incidence of adverse events during the forest-bathing or city-walking interventional period
Key secondary outcomes
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
Forest bathing - Washout - City-walking
Interventions/Control_2
City-walking - Washout - Forest bathing
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 prescreening, participate in city walking and forest bathing, consume the prescribed food, answer the questionnaire, wear Fitbit Inspire 3, have blood draws and stool collections, and remain at rest according to the schedule requested by the research personnel
4)Individuals who own a smartphone that can install the Fitbit app and who are able to agree to the terms of use of Fitbit Inspire 3 and the app
5)Individuals who have no problem with city walking and forest bathing walks
6)Individuals who exercise at least once a week
7)Individuals with a T score of 30 or greater and less than 70 on the Profile of Mood States-Second Edition (POMS2) test during prescreening
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 who currently have or previously had gastrointestinal, cardiovascular, endocrine, inflammatory (immunological), neuropsychiatric, 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
3)Individuals considered to have difficulty in wearing Fitbit Inspire 3
4)Individuals who plan to stay overseas with overnight accommodation between the preliminary examination and follow-up examination
5)Individuals with food allergy
6)Individuals with smoking habits
7)Individuals with an intense fear of or an aversion to insects and reptiles such as snakes
8)Individuals who donated blood within 12 weeks prior to the preliminary examination
9)Individuals who are currently participating in another study or are scheduled to participate in one during the intervention period
10)Individuals who are estimated inappropriate 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 | 07 | Month | 28 | 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 | 07 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 19 | 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 | 07 | Month | 28 | Day |
Last modified on
| 2025 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067000
