Healthy adults
Conditions
Interventions
Intake of test foods for 4 weeks before going to bed.
Intake of placebo foods for 4 weeks before going to bed.
Sponsors
EZAKI GLICO Co., Ltd.
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 who are currently receiving drug treatment due to some kind of illness (2) Subjects with a history of serious illnesses with digestive organs, liver, kidneys, heart, lungs, blood, etc. (3)Subjects who may have allergic reactions due to the ingredients of the test product (4) Subjects who are pregnant or may be pregnant, and those who are breastfeeding (5) Subjects whose lifestyle may change during the examination period (night shift, long trip, work transfer, etc.) (6) Subjects with sleep apnea (7)Subjects with severe allergies (8) Subjects with arrhythmia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Evaluate of subjective sleep(OSA sleep inventory MA version, Pittsburgh Sleep Quality Index (PSQI), VAS), autonomic function test(LF,HF,LF/HF,TP), IL-6 in serum, VAS on fatigue | — |
Secondary
| Measure | Time frame |
|---|---|
| Profile of Mood States 2nd Edition, Cognitive function evaluation(Stroop Test, Shifting Attention, Continuous Performance, Four Part Continuous Performance) | — |
Countries
Japan
Contacts
Public ContactMasaki Furuya
EZAKI GLICO Co., Ltd R&D LABORATORY
Outcome results
None listed