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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037557
Receipt No. R000042820
Scientific Title Relationships between genetic polymorphism and physio-psychological response
Date of disclosure of the study information 2019/07/31
Last modified on 2019/07/31

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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
20 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 Shigeki
Middle name
Last name Watanuki
Organization Faculty of Design, Kyushu University
Division name Department of Human Science
Zip code 815-8523
Address Shiobaru, Minami-ku, Fukuoka City, Fukuoka Prefecture, Japan
TEL +81-92-553-4543
Email watanuki@design.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Midori
Middle name
Last name Motoi
Organization Faculty of Design, Kyushu University
Division name Department of Human Science
Zip code 815-8523
Address 4-9-1 Shiobaru, Minami-ku, Fukuoka City, Fukuoka Prefecture, Japan
TEL +81-92-553-4543
Homepage URL
Email motoi.midori.266@m.kyushu-u.ac.jp

Sponsor
Institute Faculty of Design, Kyushu University
Institute
Department

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
Email 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
2024 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
2019 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.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


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