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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031944
Receipt No. R000036484
Scientific Title Effect of the difference in daytime light-source colors on nighttime hormone secretion
Date of disclosure of the study information 2018/03/28
Last modified on 2018/03/28

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Basic information
Public title Effect of the difference in daytime light-source colors on nighttime hormone secretion
Acronym Effect of the difference in daytime light-source colors on nighttime hormone secretion
Scientific Title Effect of the difference in daytime light-source colors on nighttime hormone secretion
Scientific Title:Acronym Effect of the difference in daytime light-source colors on nighttime hormone secretion
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm that the difference in daytime light-source colors (blue/red) can affect the nocturnal hormone secretion in human
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in nighttime melatonin secretion between baseline and after intervebtion
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 [First intervention]
Daytime blue-enriched light exposure
[Second intervention]
Daytime red-enriched light exposure

These interventions will be performed more than a week apart from each other
Interventions/Control_2 [First intervention]
Daytime red-enriched light exposure
[Second intervention]
Daytime blue-enriched light exposure

These interventions will be performed more than a week apart from each other
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Healthy adult male
Key exclusion criteria 1) Mental diseases
2) Extreame morningness-type
3) Extreame eveningness-type
4) Sleep disorder
5) Smorker
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoko Wakamura
Organization Graduate School of Medicine, Kyoto University
Division name Human Health Sciences
Zip code
Address 53 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto-city, Kyoto
TEL 075-751-3974
Email wakamura.tomoko.5v@kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Wakamura
Organization Graduate School of Medicine, Kyoto University
Division name Human Health Sciences
Zip code
Address 53 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto-city, Kyoto
TEL 075-751-3974
Homepage URL
Email wakamura.tomoko.5v@kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 03 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
2018 Year 03 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 28 Day
Last modified on
2018 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036484

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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