UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031944 |
|---|---|
| Receipt number | 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 16:06:24 |
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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
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
wakamura.tomoko.5v@kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036484
