UMIN-CTR Clinical Trial

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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