Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062070) titled 'Effects of Continuous Intake of a Test Food on Subjective Sleep quality: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study' on July 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Macromill Carenet , Inc.

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

Objective: Narrative objectives1 - To evaluate the effects of 12-week continuous intake of the test food on subjective sleep quality in healthy men and women aged 40 to 59 years who are dissatisfied with their sleep quality. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Continuous intake of the test food for 12 weeks Interventions/Control_2 - Continuous intake of the placebo food for 12 weeks

Eligibility: Age-lower limit - 40 years-old = Gender - Male and Female Key inclusion criteria - (1) Men and women aged 40 to 59 years at consent. (2) Aware of sleepiness or fatigue upon awakening, or poor sleep quality in daily life. (3) Provided electronic informed consent with sufficient understanding of the study. Key exclusion criteria - (1) History or current serious disease. (2) Receiving treatment or medication for chronic diseases affecting study results. (3) Disorders affecting the study (e.g., insomnia, overactive bladder, nocturia (2 or more times/night), depression, psychiatric or neurological disorders). (4) Diagnosed with or suspected of having sleep apnea. (5) Using drugs or supplements affecting study (e.g., sleep, fatigue, mood, menopause, autonomic nervous function). (6) Current treatment or management for sleep disorders, fatigue, stress, or psychiatric disorders. (7) Hormone use within 3 months before consent. (8) Living or bedding conditions where sleep is disturbed by third parties (e.g., infants, preschool children, or care recipients). (9) Night or shift work, or heavy labor within 2 months before consent, or planning to engage in such work during the study period. (10) Average time in bed of less than 5 hours. (11) Excessive alcohol or caffeine consumption, smoking, or BMI greater than 30. (12) Risk of allergy related to the study foods. (13) Risk of seasonal allergies interfering with sleep or daily life. (14) Overseas travel within 2 weeks before consent or major lifestyle or sleep environment changes planned. (15) Pregnant, lactating, or planning pregnancy. (16) Treatment or medication for menopausal disorders or hot flashes. (17) Inability to follow study procedures. (18) Participation in other clinical studies within 1 month before consent or during the study. (19) Judged inappropriate for participation by the investigator. Target Size - 176

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 11 Day Date of IRB - 2026 Year 06 Month 18 Day Anticipated trial start date - 2026 Year 07 Month 01 Day Last follow-up date - 2026 Year 12 Month 29 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071022

Disclaimer: Curated by HT Syndication.