UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034109 |
|---|---|
| Receipt number | R000038880 |
| Scientific Title | Effects of Food Containing Asparagus Extract (ONR-8) on sleep conditions in shift workers |
| Date of disclosure of the study information | 2018/09/12 |
| Last modified on | 2018/09/12 10:51:33 |
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Basic information
Public title
Effects of Food Containing Asparagus Extract (ONR-8) on sleep conditions in shift workers
Acronym
Effects of Food Containing Asparagus Extract on sleep conditions in shift workers
Scientific Title
Effects of Food Containing Asparagus Extract (ONR-8) on sleep conditions in shift workers
Scientific Title:Acronym
Effects of Food Containing Asparagus Extract on sleep conditions in shift workers
Region
| Japan |
Condition
Condition
sleep disorder
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of food containing asparagus extract (ONR-8) on sleep conditions in shift workers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Quality of sleep (Pittsburgh Sleep Quality Index)
Key secondary outcomes
Psychomotor Vigilance. Task(PVT)
Presenteeism (WFun)
Psychological distress (K6)
Work engagement
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake the Food containing asparagus extract once a day for 4 weeks
Interventions/Control_2
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 and Female
Key inclusion criteria
nurses who work on a two-shift system and feel sleep disorders
Key exclusion criteria
workers who are in treatment of depression, sleep apnea disorders, narcolepsy, narcolepsy, etc.
workers who take antidepressant drugs or sleeping medicine
workers who live with their children below school age
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohisa Nagata |
Organization
University of Occupational and Environmental Health, Japan
Division name
Institute of Industrial Ecological Sciences
Zip code
Address
Iseigaoka 1-1, Yahatanishi-ku, Kitakyushu-city Fukuoka
TEL
093-603-1611
tomohisa@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohisa Nagata |
Organization
University of Occupational and Environmental Health, Japan
Division name
Institute of Industrial Ecological Sciences
Zip code
Address
Iseigaoka 1-1, Yahatanishi-ku, Kitakyushu-city Fukuoka
TEL
093-603-1611
Homepage URL
tomohisa@med.uoeh-u.ac.jp
Sponsor or person
Institute
Institute of Industrial Ecological Sciences, University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
Otsuka Parmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
産業医科大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 12 | 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 | 09 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 12 | Day |
Last modified on
| 2018 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038880
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
