UMIN-CTR Clinical Trial

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
Email	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
Email	Mizokami.Tsubasa@otsuka.jp

Sponsor
Institute	Otsuka Pharmaceutical Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050627