UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059036 |
|---|---|
| Receipt number | R000067527 |
| Scientific Title | Effects of Breakfast and Supplemental Food Intake on Physiological and Psychological Outcomes in Young Adults with Irregular Breakfast Habits: A Randomized Parallel-Group Comparison Study |
| Date of disclosure of the study information | 2025/09/09 |
| Last modified on | 2025/09/09 15:57:12 |
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Basic information
Public title
Effects of Breakfast and Supplemental Food Intake on Physiological and Psychological Outcomes in Young Adults with Irregular Breakfast Habits: A Randomized Parallel-Group Comparison Study
Acronym
Effects of Breakfast and Supplemental Food Intake on Physiological and Psychological Outcomes in Young Adults with Irregular Breakfast Habits: A Randomized Parallel-Group Comparison Study
Scientific Title
Effects of Breakfast and Supplemental Food Intake on Physiological and Psychological Outcomes in Young Adults with Irregular Breakfast Habits: A Randomized Parallel-Group Comparison Study
Scientific Title:Acronym
Effects of Breakfast and Supplemental Food Intake on Physiological and Psychological Outcomes in Young Adults with Irregular Breakfast Habits: A Randomized Parallel-Group Comparison Study
Region
| Japan |
Condition
Condition
Individuals who habitually skip breakfast
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of breakfast and a mid-morning snack (supplemental meal) on concentration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective and Objective Concentration
Subjective concentration will be assessed using a 10cm Visual Analog Scale (VAS) after a calculation task performed every 30 minutes.
Objective concentration will be evaluated by the number of calculations and the number/rate of correct answers on a calculation task performed every 30 minutes. Furthermore, alpha, beta, and theta waves will be measured using a portable electroencephalograph (EEG, ZA-X, Proassist).
Key secondary outcomes
Hunger, satiety, and sleepiness will be assessed every 30 minutes using a 10cm Visual Analog Scale (VAS). Blood glucose levels will be measured using a Continuous Glucose Monitor (CGM).
Sleep quality, as well as bedtime and wake-up times, will be evaluated using the Athens Insomnia Scale (AIS), a morning sleepiness questionnaire, and daily logs. An actigraph will also be used for evaluation.
Overall Quality of Life will be assessed using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36v2), and mood states will be evaluated using the Profile of Mood States 2nd Edition (POMS 2).
Body composition will be measured using the TANITA MC-780. Dietary habits will be assessed through photographic meal records. Core body temperature will be measured using CORE (greenTEG AG), and autonomic nervous activity will be measured using a heart rate monitor (WHS-1, Union Tool Co., Ltd.).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Skipping breakfast as usual
Interventions/Control_2
Ingest the prescribed breakfast by 8:00 AM.
Interventions/Control_3
Consume the designated breakfast by 8:00 AM, and the designated supplemental meal around 10:30 AM.
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
| 18 | years-old | <= |
Age-upper limit
| 24 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
#1.Individuals aged 18 to 24 years old at the time of informed consent.
#2.Individuals who can provide written informed consent for participation in this study.
#3.Individuals who habitually skip breakfast on three or more weekdays out of five.
#4.Individuals who typically wake up by around 8:00 AM.
#5.Individuals who perceive difficulty in maintaining concentration during the morning and do not have a habit of taking naps.
#6.Non-smokers (Individuals who do not have a smoking habit).
Key exclusion criteria
#1.Individuals currently undergoing treatment for sleep disorders such as insomnia, or those self-administering over-the-counter sleep aids.
#2.Individuals with a past or present diagnosis of an eating disorder.
#3.Individuals currently undergoing treatment for mental illnesses such as depression.
#4.Women who are pregnant, potentially pregnant, breastfeeding, or desiring pregnancy.
#5.Individuals with food allergies.
#6.Any other individuals deemed inappropriate by the principal investigator or co-investigators.
Target sample size
66
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
7398521
Address
1-7-1 Kagamiyama, Higashi-Hiroshima, Hiroshima, Japan
TEL
0824246589
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
7398521
Address
1-7-1 Kagamiyama, Higashi-Hiroshima, Hiroshima, Japan
TEL
0824246589
Homepage URL
hogata@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd.
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
Hiroshima University
Address
1-7-1 Kagamiyama, Higashi-Hiroshima, Hiroshima, Japan
Tel
0824246589
hogata@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
広島大学（広島県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 09 | Month | 09 | Day |
Last modified on
| 2025 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067527
