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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Healthy participants | |
Classification by specialty |
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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.
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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 |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Participants who fully understand the research plan and are able to give his/her consent.
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Key exclusion criteria | People with some illness or who are not able to give consent.
Inappropriate people as a subject judged by the researcher. |
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Target sample size | 800 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
watanuki@design.kyushu-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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)
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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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |