Tokyo, June 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061841) titled 'Effects of Plant-Derived ingredients on Sleep' on June 19.

Study Type: Interventional

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

Primary Sponsor: Institute - Kao Corporation

Condition: Condition - Not applicable Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the effect of plant-derived extracts on sleep. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants will take the active test product once daily for 2 consecutive weeks, followed by a 1-week washout period, and then take the placebo test product once daily for 2 consecutive weeks. Interventions/Control_2 - Participants will take the placebo test product once daily for 2 consecutive weeks, followed by a 1-week washout period, and then take the active test product once daily for 2 consecutive weeks.

Eligibility: Age-lower limit - 30 years-old = Gender - Male Key inclusion criteria - 1. Japanese men aged 30-59 years who were born and raised in Japan, and whose cohabiting family members were also born and raised in Japan. 2. Individuals who self-report that their sleep is light/shallow or easily interrupted. 3. Individuals who agree to wear a wearable device (Fitbit). 4. Individuals with an AIS (Athens Insomnia Scale) >= 6 and = 35 kg/m^2. 3. Urination >= 3 times/night (nocturia). 4. Difficulty maintaining continuous night sleep due to caregiving/cohabitants and/or living environment. 5. Scheduled major medical intervention during study (e.g., hospitalization, surgery). 6. Severe underlying disease (cardiac, hepatic, or renal). 7. History of psychiatric disorders (e.g., depression, ADHD). 8. Current continuous use, or planned start during study: hypnotics, antidepressants, or anxiolytics. 9. Continuous use within past 1 month (>= 3 times/week), or planned start during study: sleep-related foods with function claims and/or supplements. 10. Allergic reactions to specific foods (e.g., anaphylaxis with respiratory distress). 11. Metal allergy. 12. Prone to skin irritation from alcohol swabs, adhesive gel, or medical tape. 13. Skin conditions at device sites (forehead, behind ear, chest, wrist, instep). 14. Prior similar tests: device wearing caused insomnia or daily-life interference (portable EEG (electroencephalogram), skin temperature logger, wearable). 15. Strong anxiety or fear about wearing/attaching devices. 16. Expected prolonged water activities (except bathing) and/or excessive sweating during study. 17. Night shifts/rotating shifts, or scheduled night shifts during study. 18. Scheduled travel with time zone changes (jet lag) during study. 19. Heavy alcohol consumption. 20. Another study participation at consent, or planned participation during the period. 21. Self or family employed by healthcare-related companies. 22. Deemed inappropriate by PI (principal investigator) (or principal physician/investigator). Target Size - 36

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 29 Day Date of IRB - 2026 Year 05 Month 29 Day Anticipated trial start date - 2026 Year 06 Month 29 Day Last follow-up date - 2026 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070742

Disclaimer: Curated by HT Syndication.