JPRN-UMIN000051909CompletedUnknown
Verification study on the effect of the test foods on improvement quality of sleep - Verification study on the effect of the test foods on improvement quality of sleep
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- APO PLUS STATION CO., LTD.
- Enrollment
- 102
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion 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.
Investigators
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