Tokyo, May 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061651) titled 'Effects of Morning Cheese Intake and Morning Light Exposure on Sleep and Daily Rhythms in Preschool Children' on May 22.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - No treatment

Primary Sponsor: Institute - Hiroshima University

Condition: Condition - Healthy preschool children Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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).

Eligibility: Age-lower limit - 3 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 Size - 200

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069047

Disclaimer: Curated by HT Syndication.