Tokyo, Feb. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060557) titled 'Sleep Status Verification Study Through Continuous Intake of Test Food' on Feb. 3.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Japan Clinical Trial Association

Condition: Condition - Healthy adult Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify the effects on sleep when the test articles is consumed continuously for 8 weeks Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Continuous intake of one packet of the test article A daily before bedtime for 8 weeks. Interventions/Control_2 - Continuous intake of one packet of the test article B daily before bedtime for 8 weeks.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1. Subjects dissatisfied with or concerned about their sleep quality 2. Subjects experiencing fatigue in daily life 3. Subjects with a BMI between 19 and 26 4. Subjects who use a smartphone and can download and use an app. Key exclusion criteria - 1. Subjects satisfied with their sleep quality, somewhat satisfied, or neither satisfied nor dissatisfied 2. Pregnant women, breastfeeding individuals, or those who may be pregnant 3. Subjects working night shifts or rotating day-night shifts 4. Subjects currently receiving medical treatment or taking prescription medication 5. Subjects diagnosed by a physician with sleep disorders such as insomnia 6. Subjects taking sleeping pills or sleep supplements (e.g., melatonin) 7. Subjects undergoing hormone replacement therapy 8. Subjects who participated in another human trial within the past month or are currently participating in one 9. Subjects whose trial date falls within 2 weeks of their most recent vaccination Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 13 Day Date of IRB - 2026 Year 01 Month 15 Day Anticipated trial start date - 2026 Year 02 Month 03 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069272

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