Verification study on the effects of intake of test foods on the improvement quality of sleep

UMIN ID: UMIN000050007

Registered date:13/01/2023

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Not applicable
• Date of first enrollment: 2023/01/13
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Daily intake of test food for 4 weeks
Daily intake of placebo (control food) for 4 weeks

Outcome(s)

• Primary Outcome: Check for "Sleepiness on rising" in the OSA sleep inventory MA version (OSA-MA)
• Secondary Outcome: "Initiation and maintenance of sleep" , "frequent dreaming", "refreshing", "sleep length" in the OSA-MA, PSQI, JESS, The sleep scope (Electroencephalogram (Initiation of sleep, Nocturnal awakening, Sleep efficiency), Sleep stage(REM/non-REM sleep)), The proportion of division or family of intestinal bacteria

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) Persons who are on treatment for a serious illness. (2) Persons whose sleep time or sleep habits are irregular because of night shift etc. (3) Persons who visit the hospital because of mental disorders (depression etc.) or sleep disorders, or were diagnosed with mental disorders at once. (4) Persons who are diagnosed Sleep Apnea Syndrome or have subjective symptoms of apnea. (5) Subjects who select "I would like to kill myself." or "I would kill myself if I had the chance." at question 9 of Beck Depression Inventory-II (BDI2) at the screening test. (6) Habitual Smokers. (7) Persons who have metal Allergy or sensitive skin. (8) Persons who may be prevented from sound sleep by the other, for instance, who have preschoolers, who nurse care, who sleep on the bed two or more. (9) Persons with food allergies or those who may be allergic to the test food. (10) Persons who regularly use licensed drugs or quasi-drugs that may affect the study. (11) Persons who regularly use health foods that may affect the study. (12) Persons who are participating in a clinical trial or have participated in another clinical trial within 3 months from the date of obtaining consent. (13) Persons unable to maintain daily routines. (14) Pregnant, lactating, or wishing to become pregnant. (15) Persons who plan to participate in other examinations during the study. (16) Other subjects who are deemed inappropriate for this study by the investigator.

Related Information

• Primary Sponsor: APO PLUS STATION CO., LTD.
• Source(s) of Monetary Support: NISSIN YORK CO.,LTD.