Clinical Trial: Evaluation of the Effects of Continued Consumption of the Study Food on Sleep: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial (Japan)

Tokyo, Oct. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059263) titled 'Evaluation of the Effects of Continued Consumption of the Study Food on Sleep: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial' on Oct. 2.

Study Type: Interventional

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

Primary Sponsor: Institute - IMEQRD Co. Ltd.

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

Objective: Narrative objectives1 - To assess the impact of four weeks of test supplement intake on sleep in individuals dissatisfied with their sleep quality. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Test supplement: 4 tablets per day, taken with water or lukewarm water Interventions/Control_2 - Placebo supplement: 4 tablets per day, taken with water or lukewarm water

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key 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 Key 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 Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 18 Day Date of IRB - 2025 Year 09 Month 16 Day Anticipated trial start date - 2025 Year 10 Month 03 Day Last follow-up date - 2025 Year 12 Month 20 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067690

Disclaimer: Curated by HT Syndication.