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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

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 - 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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059036
Enrollment
66
Registered
2025-09-09
Start date
2025-11-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Individuals who habitually skip breakfast

Interventions

Skipping breakfast as usual Ingest the prescribed breakfast by 8:00 AM. Consume the designated breakfast by 8:00 AM, and the designated supplemental meal around 10:30 AM.

Sponsors

Hiroshima University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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).

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
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.).

Countries

Japan

Contacts

Public ContactHitomi Ogata

Hiroshima University Graduate School of Humanities and Social Sciences

hogata@hiroshima-u.ac.jp0824246589

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026