Verification study on the effect of the test foods on improvement quality of sleep

UMIN ID: UMIN000051909

Registered date:15/08/2023

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Not applicable
• Date of first enrollment: 2023/08/16
• Target sample size: 102
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Daily intake of test food for 8 weeks
Daily intake of placebo (control food) for 8 weeks

Outcome(s)

• Primary Outcome: OSA sleep inventory MA version (OSA-MA), Visual analogue scale for sleep
• Secondary Outcome: OSA-MA (initiation and maintenance of sleep, frequent dreaming, refreshing, sleep length), AIS, JESS, Electroencephalogram (initiation of sleep, nocturnal awakening, sleep efficiency, REM/non-REM sleep), Fitbit Versa 3 ( snore, noise level, sleep score), The proportion of division and family of intestinal bacteria

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1)Those who are on treatment for a serious illness. (2)Those who are at late night work, shift work, or heavy work. (3)Those whose sleep time or sleep habits are irregular on weekdays. (4)Those who visit the hospital because of mental disorders (depression etc.) or sleep disorders, or who have been diagnosed with mental disorders. (5)Those who have been diagnosed as Sleep Apnea Syndrome or have subjective symptoms of apnea. (6)Those 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. (7)Those who are habitual smokers. (8)Those who are in the habit of consuming foods that inhibit sleepiness before bedtime or using devices that inhibit sleepiness. (9)Those who with metal Allergies or sensitive skin. (10)Those who may be prevented from sleep by others, including preschoolers, care required, one(s) who share bedroom. (11)Those with food allergies or those who may be allergic to the test food. (12)Those who regularly use licensed drugs or quasi-drugs that may affect the study. (13)Those who regularly use health foods that may affect the study. (14)Those who are participating in a clinical trial or have participated in another clinical trial within 1 months from the date of obtaining consent. (15)Those who may be unable to maintain their daily lifestyle. (16)Those who are pregnant or breastfeeding or planning to become pregnant during the study. (17)Those who plan to participate in any other clinical trial during the study. (18)Those 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.