UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044323 |
|---|---|
| Receipt number | R000050627 |
| Scientific Title | Sleep evaluation study after intake of the test food in health care workers |
| Date of disclosure of the study information | 2021/05/26 |
| Last modified on | 2021/12/02 11:05:12 |
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Basic information
Public title
Sleep evaluation study after intake of the test food in health care workers
Acronym
Sleep evaluation study after intake of the test food in health care workers
Scientific Title
Sleep evaluation study after intake of the test food in health care workers
Scientific Title:Acronym
Sleep evaluation study after intake of the test food in health care workers
Region
| Japan |
Condition
Condition
Healthy Volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effects of the test food on sleep in health care workers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep-related indices (3DSS and sleep duration, awake time, sleep score, heart rate during sleep, autonomic function)
Key secondary outcomes
(Secondary outcomes)
Discomfort due to wearing masks, fatigue and stress at work, number of errors at work
(Safety evaluation)
General physical findings (subjective symptoms, objective findings), vital signs (weight, body temperature, blood pressure, pulse rate), frequency of adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
4-weeks intake of the test food without shift work
Interventions/Control_2
4-weeks intake of the placebo food without shift work
Interventions/Control_3
4-weeks intake of the test food with shift work
Interventions/Control_4
4-weeks intake of the placebo food with shift work
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Persons who have obtained written consent for participation in the research.
2)Healthy men and women.
3)Persons who have undergone a physical examination within one year.
4)Persons who can take test foods, etc. and maintain rest according to the schedule instructed by researchers.
Key exclusion criteria
1)Persons who have or had disorder in digestive, circulatory or endocrine system and who are estimated inappropriate to this study.
2)Persons who have allergy.
3)Others who are judged unsuitable as subjects by principal investigator or principal researcher (e.g., sleep apnea syndrome).
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yasutaka |
| Middle name | |
| Last name | Ikeda |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho Kanzakigun, Saga, Japan
TEL
0952-52-1522
Ikeda.Yasutaka@otsuka.jp
Public contact
Name of contact person
| 1st name | Tsubasa |
| Middle name | |
| Last name | Mizokami |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho Kanzakigun, Saga
TEL
0952-52-1522
Homepage URL
Mizokami.Tsubasa@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Jeneral foundation Tohoku-seishin-hokenkai Aoba hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Otsuka Pharmaceutical Co., Ltd.
Address
Shinagawa Grand Central Tower, 2-16-4, Konan, Minato-ku, Tokyo
Tel
03-6717-1499
shimizu_se@otsuka.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
| 2021 | Year | 05 | Month | 26 | 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
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 25 | Day |
Last modified on
| 2021 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050627
