UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043237 |
|---|---|
| Receipt number | R000049341 |
| Scientific Title | Effect of breakfast on physiological indices of healthy humans for those who eat 3 meals and 2 meals a day |
| Date of disclosure of the study information | 2021/02/03 |
| Last modified on | 2022/08/06 09:25:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hogata@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049341
