UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061651 |
|---|---|
| Receipt number | R000069047 |
| Scientific Title | Effects of Morning Cheese Intake and Light Exposure on Sleep and Activity Rhythms, Health, and Developmental Outcomes in Preschool Children: A Chrononutritional Intervention Study |
| Date of disclosure of the study information | 2026/05/22 |
| Last modified on | 2026/05/22 02:33:29 |
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Basic information
Public title
Effects of Morning Cheese Intake and Morning Light Exposure on Sleep and Daily Rhythms in Preschool Children
Acronym
CHIME-Kids Study: Morning Cheese Intake and Light Exposure for Kids
Scientific Title
Effects of Morning Cheese Intake and Light Exposure on Sleep and Activity Rhythms, Health, and Developmental Outcomes in Preschool Children: A Chrononutritional Intervention Study
Scientific Title:Acronym
CHIME-Kids Trial: CHeese Intake and Morning light Exposure in Kids
Region
| Japan |
Condition
Condition
Healthy preschool children
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of a combined lifestyle intervention consisting of morning cheese intake and extended morning outdoor activity on nocturnal sleep duration at week 4 and related sleep wake rhythm outcomes in preschool children using a cluster randomized controlled trial at the kindergarten nursery school level
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Nocturnal sleep duration at week 4 assessed by actigraphy MTN-221 using the mean of three consecutive weekdays excluding days adjacent to weekends
Key secondary outcomes
1 Nocturnal sleep duration at week 5 assessed by actigraphy
2 Light exposure metrics assessed by light sensor including morning and afternoon illuminance and time above 1000 lx
3 Urinary aMT6s and creatinine adjusted aMT6s Cr
4 Parent reported outcomes including PedsQL SDQ and parenting stress questionnaires
5 Sleep architecture indices (sleep efficiency, sleep onset latency, number and duration of nocturnal awakenings) measured by actigraphy MTN-221
6 Sleep rhythm indices (mean weekday bedtime and wake time, day-to-day variability of bedtime)
7 Total 24-hour sleep duration including daytime naps measured by actigraphy
8 Physical activity (energy expenditure adjusted by basal metabolic rate) measured by actigraphy
9 Media device exposure time assessed by time-use record
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Intervention group: 4 weeks. At home, participants consume 1 piece of processed cheese (approx 17 g) once daily at breakfast (within 2 hours after waking). In addition, the nursery/kindergarten extends outdoor activity time in the morning (9:00-12:00) by 30 minutes as part of routine childcare; when outdoor activity is not feasible, activities are conducted indoors in a bright environment.
Interventions/Control_2
Control group: 4 weeks. Usual lifestyle without additional food intervention or extended morning outdoor activity (no treatment control).
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
| 3 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Children aged 3-6 years at study start
2. Enrolled in a nursery school, kindergarten, or certified child center in Fuchu Town, Aki-gun, Hiroshima, and attending at least 4 days per week
3. Written informed consent obtained from a parent or legal guardian
4. No food allergy to dairy products (milk, cheese, yogurt, etc)
5. Expected to continue attending the same institution during the study period
Key exclusion criteria
1. Diagnosed sleep disorder currently under treatment
2. Severe chronic disease requiring dietary restriction
3. Diagnosed lactose intolerance or history of gastrointestinal symptoms after dairy intake
4. Marked difficulty in wearing the actigraph or completing study procedures (including parent judgement)
5. Planned continuous absence from the institution for 1 week or longer during the study period
6. Other reasons judged inappropriate by the investigators
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Norihisa |
| Middle name | |
| Last name | Tamura |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8524
Address
1-1-1 Kagamiyama, Higashi-Hiroshima city, Hiroshima, Japan
TEL
0824246803
tamura65@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Norihisa |
| Middle name | |
| Last name | Tamura |
Organization
Hiroshima University
Division name
Graduate School of Humanities and Social Sciences
Zip code
739-8524
Address
1-1-1 Kagamiyama, Higashi-Hiroshima city, Hiroshima, Japan
TEL
0824246803
Homepage URL
tamura65@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Norihisa Tamura
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Megmilk Snow Brand Co., Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@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 | 05 | Month | 22 | 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
| 2026 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 22 | Day |
Last modified on
| 2026 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069047
