UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037557 |
|---|---|
| Receipt number | R000042820 |
| Scientific Title | Relationships between genetic polymorphism and physio-psychological response |
| Date of disclosure of the study information | 2019/07/31 |
| Last modified on | 2024/01/29 09:31:52 |
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Basic information
Public title
Relationships between genetic polymorphism and physio-psychological response
Acronym
Relationships between genetic polymorphism and physio-psychological response
Scientific Title
Relationships between genetic polymorphism and physio-psychological response
Scientific Title:Acronym
Relationships between genetic polymorphism and physio-psychological response
Region
| Japan |
Condition
Condition
Healthy participants
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify relationships between genetic polymorphism, epigenetics and physio-psychological responses under various environments including cold, hot, low-plessure and under sleep.
Basic objectives2
Others
Basic objectives -Others
Physiological response
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of relationships between metabolic related genes, hypoxia-inducible factor (HIF) and clock genes and changes of body temperature, DLMO, metabolic index and SpO2.
Key secondary outcomes
Association between genetic data and personal information (sex, age, body mass index), physiological measurements (ECG, EEG), salivary and blood hormones, cytokines (interferon/ adipokine) and fatty acids.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Expose to the cold environment 10 degree Celsius) for 120 minutes.
Interventions/Control_2
Expose to the hot environment 40 degree Celsius) for 120 minutes.
Interventions/Control_3
Expose to hypobaric hypoxic environments 0.9 atm for 120 minutes.
Interventions/Control_4
Expose to hypobaric hypoxic environments 0.7 atm for 120 minutes.
Interventions/Control_5
Simulated night shift work under 500 lux bright lighting environment for 6 hours.
Interventions/Control_6
Simulated night shift work under dim lighting environment for 6 hours.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants who fully understand the research plan and are able to give his/her consent.
Key exclusion criteria
People with some illness or who are not able to give consent.
Inappropriate people as a subject judged by the researcher.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Maeda |
Organization
Faculty of Design, Kyushu University
Division name
Department of Human Life Design and Science
Zip code
815-8523
Address
Shiobaru, Minami-ku, Fukuoka City, Fukuoka Prefecture, Japan
TEL
+81-92-553-4522
maeda@design.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Maeda |
Organization
Faculty of Design, Kyushu University
Division name
Department of Human Life Design and Science
Zip code
815-8523
Address
4-9-1 Shiobaru, Minami-ku, Fukuoka City, Fukuoka Prefecture, Japan
TEL
+81-92-553-4522
Homepage URL
maeda@design.kyushu-u.ac.jp
Sponsor or person
Institute
Faculty of Design, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Japan society for promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Section of IRB & Ethics Committee Administration, Administration Department (University Hospital), Kyushu University
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-City, Fukuoka-Prefecture, Japan
Tel
+81-92-642-5082
bynintei@jimu.kyushu-u.ac.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
| 2019 | Year | 07 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 07 | Month | 31 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042820
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
