Healthy Japanese adults
Conditions
Interventions
Duration: 4weeks Test materials: Lactobacillus brevis SBC8803 (SBL88TM) sterilized lactic acid bacterial cells 25 mg (2.5 x 1010cells) Dose: Take a tablet once a day Administration: Take a tablet
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adults 2. Subjects who feel quality of sleep dissatisfaction 3. Subjects who are judged as eligible to participate in the study by the principal investigator 4. Subjects who are considered as appropriate for the study by the principal investigator based on the score of Beck Depression Inventory 5. Among the subjects who passed 3. and 4., subjects who have a relatively lower score of OSA sleep inventory MA version at screening and examination before ingestion
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, sleep apnea syndrome, or other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 4. Currently taking medicines (include herbal medicines) and supplements 5. Subjects who are allergic to medicines and/or the test food related products 6. Subjects who are pregnant, breast-feeding, and plan to become a pregnant 7. Subjects who live with their infants less than 1 year old 8. Subjects who co-sleep with their children (1 to 6 years old) 9. Subjects who live with requiring long-term care persons 10. Subjects who share the bed with more than one person 11. Subjects who work late-night shift and the life-styles are irregular 12. Subjects whose body mass index (BMI) is 25 kg/m2 or more 13. Subjects who wake up for urination 3 times or more during nocturnal sleep 14. Subjects whose dinner time is extremely irregular 15. Subjects who are troubled with pollen allergy or asthma 16. Subjects who drink alcohol heavily 17. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 18. Subjects who are judged as ineligible to participate in the study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. OSA sleep inventory MA version *Fill it in immediately after waking up at home on the examination day and two days before | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sleep test (Sleep Scan) 2. Athens Insomnia Scale (AIS) 3. Japanese version of Epworth Sleepiness Scale (JESS) 4. Beck Depression Inventory 5. Visual Analogue Scale (VAS) of subjective symptoms *1 Perform it at subject's home 1 week before screening and examination and during the test period *2-5 Assess these at 0 and 4 weeks after consuming | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed