UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059832 |
|---|---|
| Receipt number | R000068420 |
| Scientific Title | Effects of a Breakfast Intake Intervention on the Circadian Rhythm of Core Body Temperature |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2025/11/20 09:29:35 |
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Basic information
Public title
Effects of a Breakfast Intake Intervention on the Circadian Rhythm of Core Body Temperature
Acronym
Effects of a Breakfast Intake Intervention on the Circadian Rhythm of Core Body Temperature
Scientific Title
Effects of a Breakfast Intake Intervention on the Circadian Rhythm of Core Body Temperature
Scientific Title:Acronym
Effects of a Breakfast Intake Intervention on the Circadian Rhythm of Core Body Temperature
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating Changes in Core Body Temperature Rhythms Following One-Month Wake-Up Time Restriction and Breakfast Intake Intervention
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Core Body Temperature Rhythms
Key secondary outcomes
Salivary melatonin levels
aMT6s in the first morning urine sample
Sleep and activity levels measured by Fitbit
Changes in morning performance
OSA Sleep Questionnaire
Meal timing
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
| Food |
Interventions/Control_1
No breakfast until noon for 4 weeks
Interventions/Control_2
Breakfast (450kcal) for 4 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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 18 years or older and under 40 years
Individuals who do not have a habit of eating breakfast
(defined as those who, on at least five days per week, typically consume only snacks, fruits, dairy products, or beverages in the morning; only nutrient supplements or energy drinks; or consume nothing at all in the morning)
Individuals who maintain generally regular eating and sleeping habits
Individuals who are able to participate during the specified study period and visit the laboratory on the designated days
Individuals who can download and use the required mobile application on their own smartphone
Key exclusion criteria
Individuals engaged in shift work or night work
Individuals with extremely irregular daily routines
Individuals who regularly use sleeping medications or sleep supplements
Individuals with allergies to any of the following foods: wheat, eggs, milk, soy, or walnuts
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Tahara |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-0037
Address
Hiroshima-shi Kasumi 1-2-3, Hiroshima
TEL
082-257-5166
yutahara@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Tahara |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-0037
Address
Hiroshima-shi Kasumi 1-2-3, Hiroshima
TEL
082-257-5167
Homepage URL
yutahara@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Other
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
082-257-5167
ed-ken-zai@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
| 2026 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 07 | 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 | 11 | Month | 20 | Day |
Last modified on
| 2025 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068420
