UMIN-CTR Clinical Trial

Basic information
Public title	Effect of breakfast on physiological indices of healthy humans for those who eat 3 meals and 2 meals a day
Acronym	Meal intervention of one day
Scientific Title	Effect of breakfast on physiological indices of healthy humans for those who eat 3 meals and 2 meals a day
Scientific Title:Acronym	Meal intervention of one day
Region	Japan

Condition
Condition	healthy subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effects of skipping breakfast for those who eat breakfast and of eating breakfast for those who omit breakfast, on glucose dynamics, hormone, and core body temperature.
Basic objectives2	Others
Basic objectives -Others	Exercise nutrition
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	glucose dynamics, heart rate variability, core body temperature, hormone
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Meal intervention of one day (people who eating breakfast every day, meal intervention to skipping breakfast)
Interventions/Control_2	Meal intervention of one day (people who omit breakfast every day, meal intervention to eat breakfast)
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	30 years-old >
Gender	Male
Key inclusion criteria	Eating breakfast every day and living a regular wake/sleep Skipping breakfast every day and living a regular wake/sleep
Key exclusion criteria	Smoker, Diabetes, People with food allergies
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Hitomi Middle name Last name Ogata
Organization	Hiroshima University
Division name	Graduate School of Humanities and Social Sciences
Zip code	739-8521
Address	1-7-1 Kagamiyama, Higashi-Hiroshima, Hiroshima, Japan
TEL	082-424-6589
Email	hogata@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Hitomi Middle name Last name Ogata
Organization	Hiroshima University
Division name	Graduate School of Humanities and Social Sciences
Zip code	739-8521
Address	1-7-1 Kagamiyama, Higashi-Hiroshima, Hiroshima, Japan
TEL	082-424-6589
Homepage URL
Email	hogata@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	Institute for Food ad Health Science, Yazuya Co. Ltd.
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Hiroshima University
Address	1-7-1 Kagamiyama, Higashi-Hiroshima, Hiroshima, Japan
Tel	082-424-6306
Email	souka-soumu@office.hiroshima-u.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	2021 Year 02 Month 03 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	15
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	2020 Year 12 Month 18 Day
Date of IRB	2019 Year 05 Month 22 Day
Anticipated trial start date	2021 Year 02 Month 03 Day
Last follow-up date	2022 Year 03 Month 31 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 02 Month 03 Day
Last modified on	2022 Year 08 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049341