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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041016
Receipt No. R000046838
Scientific Title Exploratory study on subjective sleep evaluation and mood state who breakfast skippers regularly eat breakfast
Date of disclosure of the study information 2020/07/06
Last modified on 2020/07/06

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Basic information
Public title Exploratory study on subjective sleep evaluation and mood state who breakfast skippers regularly eat breakfast
Acronym Effects of eating breakfast regularly on subjective sleep quality and mood states
Scientific Title Exploratory study on subjective sleep evaluation and mood state who breakfast skippers regularly eat breakfast
Scientific Title:Acronym Effects of eating breakfast regularly on subjective sleep quality and mood states
Region
Japan

Condition
Condition Healthy Adults
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigated the effect of eating breakfast regularly for eight weeks on people who usually skip breakfast. We examined the effects on the participants' subjective quality of sleep and mood states.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Subjective sleep quality
Key secondary outcomes Mood states
Body composition

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 The intervention subjects were those who usually skipped breakfast more than 5 times a week. The subjects were instructed to eat a breakfast containing a staple food (i.e., rice, bread, noodles, or cereals) each day for 8 weeks.
Interventions/Control_2 The control subjects were those who usually ate breakfast at least 5 times a week. The subjects were instructed to eat a breakfast containing a staple food (i.e., rice, bread, noodles, or cereals) each day for 8 weeks.
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 1.Healthy adults over 20 years of age
2.Office workers who worked in the city of Yokohama, Japan
3.People who provided written consent for participation
Key exclusion criteria 1.Patients with severe liver, kidney, heart, lung, or blood disease or with psychiatric disorders;
2.People who wished to become pregnant, were pregnant, or were breastfeeding during this survey
3.People using a cardiac pacemaker
4.People whose supervisors judged participation to be inappropriate.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yoko
Middle name
Last name Suga
Organization Kanto Gakuin University
Division name College of Nutrition
Zip code 236-8501
Address 1-50-1 Mutsuura-higashi, Kanazawa-ku, Yokohama, Kanagawa, 236-8501, Japan
TEL 045-786-8649
Email yoko@kanto-gakuin.ac.jp

Public contact
Name of contact person
1st name Katsuyuki
Middle name
Last name Ishihara
Organization Calbee, Inc.
Division name Research & Development Division
Zip code 321-3231
Address 23-6, Kiyohara-kogyodanchi, Utsunomiya, Tochigi, 321-3231, Japan
TEL 080-5952-8671
Homepage URL
Email k_ishihara@calbee.co.jp

Sponsor
Institute Kanto Gakuin University
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 Kanto Gakuin University
Address 1-50-1 Mutsuura-higashi, Kanazawa-ku, Yokohama, Kanagawa, 236-8501, Japan
Tel 045-786-2924
Email sangaku@kanto-gakuin.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
2020 Year 07 Month 06 Day

Related information
URL releasing protocol https://www.calbee.co.jp/
Publication of results Unpublished

Result
URL related to results and publications https://www.calbee.co.jp/
Number of participants that the trial has enrolled 194
Results
Significant difference in major outcomes
Results date posted
2020 Year 07 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy Adults
Participant flow
Intervetion Group:Eighty-six subjects completed. Control Group:Sixty-nine subjects completed
Adverse events
No adverse effect reported
Outcome measures
Subjective sleep quality
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 10 Month 15 Day
Date of IRB
2017 Year 12 Month 22 Day
Anticipated trial start date
2017 Year 12 Month 23 Day
Last follow-up date
2018 Year 12 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 06 Day
Last modified on
2020 Year 07 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046838

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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