UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the fatigue stress improvement by the breakfast for breakfast skipper of medical staff
Acronym	Examination of the fatigue stress improvement by the breakfast for breakfast skipper of medical staff
Scientific Title	Examination of the fatigue stress improvement by the breakfast for breakfast skipper of medical staff
Scientific Title:Acronym	Examination of the fatigue stress improvement by the breakfast for breakfast skipper of medical staff
Region	Japan

Condition
Condition	breakfast skipper
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	fatigue stress improvement by breakfast
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of the autonomic nerve function 4 weeks later
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	breakfast eating
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	breakfast skipper
Key exclusion criteria	allergy for cereals
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Tomotaka Middle name Last name Dohi
Organization	Juntendo University Hospital
Division name	Cardiovascular biology and Medicine
Zip code	113-8431
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3813-3111
Email	h-ebina@juntendo.ac.jp

Public contact
Name of contact person	1st name Hideki Middle name Last name Ebina
Organization	Juntendo University Hospital
Division name	Cardiovascular biology and Medicine
Zip code	113-8431
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3813-3111
Homepage URL
Email	h-ebina@juntendo.ac.jp

Sponsor
Institute	Juntendo University Hospital
Institute
Department

Funding Source
Organization	Calbee, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Juntendo University Hospital
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel	03-3813-3111
Email	h-ebina@juntendo.ac.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	2022 Year 06 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	50
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	2019 Year 12 Month 13 Day
Date of IRB	2019 Year 12 Month 13 Day
Anticipated trial start date	2020 Year 02 Month 12 Day
Last follow-up date	2021 Year 11 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 06 Month 27 Day
Last modified on	2022 Year 06 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046073