Healthy adults
Conditions
Interventions
Intake one bottle (100 mL) of fermented soymilk beverage a day, eight continuous weeks.
Intake one bottle (100 mL) of unfermented placebo soymilk beverage a day, eight continuous weeks.
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adult Male and female who are 30 or more and under 60 years of age at the time of informed consent 2. Subjects who are having sleep dissatisfaction 3. Subjects whose average sleep time on weekdays falls in 4 hours or more and 7 hours or less 4. Patients who have been fully informed of the content of this clinical study and personally provided voluntary written informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects who have or have a history of mental illness, chronic tiredness diseases, sleep impediment 2. Subjects who have been diagnosed with sleep apnea syndrome, or who are aware or suspected of having it 3. Subjects who have or have a medical history of disorders that affect the secretion of adrenocortical hormones, and/or metabolic disorder 4. Subjects who are currently receiving drug treatment 5. Subjects who are making an attempt to improve stress, sleep, and fatigue by taking functional foods or receiving therapies 6. Subjects who have severe allergic rhinitis (taking and using medicine daily) 7. Subjects who wake up for urination 2 times or more during nocturnal sleep 8. Subjects who diagnosed with overactive bladder or undergoing treatment 9. Subjects who diagnosed with reflux esophagitis or undergoing treatment 10. Subjects who are unable to sleep alone on a single bedding 11. Subjects who are in living condition that can disturb their own sleep 12. Subjects who are currently taking or planning to take medicine for pollen allergy during this study period 13. Subjects who have smoking habits 14. Subjects who daily take excessive alcohol 15. Subjects who work on irregular shifts 16. Subjects who engage in physical labor 17. Subjects who have exercise habits during night time and are unable to stop vigorous exercise by 2 hours before bedtime 18. Subjects whose sleeping environment is likely to change significantly during the study period due to a long trip or some others 19. Subjects who using pacemakers 20. Subjects who have drug and food allergies 21. Females who are pregnant, intend to become pregnant, or breast-feeding 22. Subjects who have a participation in another interventional clinical study within the last 4 weeks, or are intended to participate 23. Subjects who have tested positive for SARS-CoV-2 within the last 4 weeks 24. Others who have been considered ineligible for the participation in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective sleep feeling measured by the MA version of the OSA sleep inventory. | — |
Secondary
| Measure | Time frame |
|---|---|
| Mood questionnaire (Visual Analogue Scale) Stress questionnaire (Visual Analogue Scale) Pittsburgh Sleep Quality Index | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Sales department
Outcome results
None listed