Healthy adults
Conditions
Interventions
Intake of test food for 3 days before going to bed.
Rest without intaking a test food for three days before going to bed.
Sponsors
Shiba Palace Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Japanese men and women whose age at the time of obtaining consent is 20 to 59 years old (2)Subjects who are dissatisfied with sleep (trouble with sleep, waking up in the middle of the night , poor sleep, daytime sleepiness) (3)Subjects whose Pittsburgh Sleep Quality Index(PSQI) score is over 6 points
Exclusion criteria
Exclusion criteria: (1) Subjects participating in other clinical trials (2) Subjects who are pregnant or may be pregnant, and those who are breastfeeding (3)Subjects who may have allergic reactions due to the ingredients of the test product (4)Subjects who go to the hospital / taking medication / obtaining treatment (5)Subjects using implantable medical electrical equipment such as pacemakers and implantable cardioverter-defibrillators that are susceptible to electromagnetic interference (6)Subjects using wearable medical electrical equipment such as electrocardiographs (7)Subjects with chronic diseases or disorders of the liver, biliary tract, digestive system, circulatory system, respiratory system, kidney, urinary system, psychiatry, nervous system, and blood system (8)Subjects with sleep apnea (9)Subjects with asthma (10)Subjects whose lifestyle may change during the examination period (night shift, long trip, work transfer, etc.) (11)Subjects whose working hours are not stable due to irregular shift work and late night work, etc. (12) Subjects with acute pain disorders such as spinal fractures, sprains, and strains (13)Subjects who need rest due to physical or mental illness or disability (14)Subjects with high blood pressure (15)Subjects with arrhythmia (16)Subjects who need the assistance of others and cannot come to the hospital during the test period by themselves (17)Subjects who cannot quit smoking or quit smoking for four days during the exam period, including the day before the exam period (18)Subjects who cannot stop taking caffeine drinks after dinner for four days during the exam period, including the day before the exam period (19)Subjects who live with preschool children (20)Subjects who have thick hair and cannot attach electrodes to their chest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| autonomic function test(LF,HF,LF/HF), Salivary Chromogranin A, OSA sleep inventory(MA version), VAS | — |
Countries
Japan
Contacts
Public ContactKo Masuda
SOUKEN Co., Ltd Management Division
Outcome results
None listed