NIPH Clinical Trials Search

Effects of Plant-Derived ingredients on Sleep

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Not applicable
Date of first enrollment	2026/06/29
Target sample size	36
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	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. 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.

Outcome(s)

Primary Outcome	Mean percentage of NREM(Non-Rapid Eye Movement) stage N3 sleep on Wednesday-Friday nights after 2-week intake of the test product containing plant-derived ingredients.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	30years-old
Age maximum	59years-old
Gender	Male
Include 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 < 16. 5. Individuals whose weekday (Monday-Friday) wake-up time is 9 am or earlier, from the month immediately prior to enrollment through the study period.
Exclude criteria	1. Sleep apnea diagnosed within past 1 year, or suspected based on snoring. 2. BMI >= 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).