Healthy adults
Conditions
Interventions
Test supplement: 4 tablets per day, taken with water or lukewarm water
Placebo supplement: 4 tablets per day, taken with water or lukewarm water
Sponsors
IMEQRD Co. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 20 to under 65 2. Japanese men and women 3. Dissatisfied with sleep quality 4. BMI under 30 kg/m^2 5. Able to enter electronic diaries via smartphone or PC 6. Fully informed of the study purpose and content, voluntarily consented in writing
Exclusion criteria
Exclusion criteria: 1. Currently receiving treatment for any disease (including medication or Kampo; as-needed use permitted except for sleep medications), or history of sleep disorders/treatment (including OTC drugs) 2. Under physician-supervised dietary or exercise therapy 3. Current or past serious illness 4. Regular use of OTC drugs, quasi-drugs, specified health foods, supplements, or functional foods (participation allowed if discontinued after consent) 5. Household with infants under 1 year 6. Sleeping with young children (aged 1 to school entry) 7. Living with individuals requiring nursing care 8. Sharing bedding with others 9. Nocturia (urinating 3 or more times per night) 10. Diagnosed with or aware of sleep apnea 11. Unable to wear the EEG device during the study 12. Unable to abstain from alcohol on EEG measurement days 13. Sensitive skin prone to irritation from adhesive tape 14. Overnight travel or business trips during the EEG device period 15. Current or past drug or food allergies 16. Excessive alcohol consumption (more than 40g pure alcohol/day) 17. Heavy smoking (more than 21 cigarettes/day) 18. Shift workers with night shifts 19. Planning major lifestyle changes (diet, sleep, exercise) during study 20. Pregnant, breastfeeding, or planning pregnancy during study 21. Participation in other clinical studies within 1 month before consent, currently, or planned during study 22. Deemed unsuitable for participation by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total score of the Japanese version of the Athens Insomnia Scale (AIS-J) after 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in AIS-J subscale scores after 4 weeks - Change in OSA Sleep Inventory MA version scores (sleepiness on waking, sleep initiation and maintenance, dreaming, recovery from fatigue, sleep duration) after 4 weeks - Change in total score of the Japanese version of the Epworth Sleepiness Scale (J-ESS) after 4 weeks - Change in POMS2 (Adult Short Version) TMD scores (AH, CB, DD, FI, TA, VA, F) after 4 weeks - Change in fatigue VAS questionnaire scores after 4 weeks - Change in Cognitrax Basic work performance scores after 4 weeks - Change in sleep EEG (SleepScope) evaluation items after 4 weeks - Change in SPQ (Single-Item Presenteeism Question) scores after 4 weeks | — |
Countries
Japan
Contacts
Public ContactHirokuni Kayama
IMEQRD Co., Ltd. Planning and Sales Department
Outcome results
None listed