Healthy Japanese subjects
Conditions
Interventions
<
Group1>
Duration: 2 weeks Test food: SBL88TM sterilized lactic acid bacterial cells 25 mg (2.5 x 1010cells) Administration: One tablet per day at any time during the day <
Group2>
Duration: 4 weeks Test food: SBL88TM sterilized lactic acid bacterial cells 25 mg (2.5 x 1010cells) Administration: One tablet per day at any time during the day <
Group3>
Duration: 4 weeks Test food: SBL88TM sterilized lactic acid bacterial cells 25 mg (2.5 x 1010cells) Administration: One tablet per day at any time during the day
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who are affiliated with Sapporo Group or ORTHOMEDICO Inc. 2. Healthy Japanese adult subjects 3. Subjects who are judged as eligible to participate in the trial by the physician 4. Subjects who can participate in the trial according to the schedule 5. Subjects who voluntary give their consent to participate in the trial
Exclusion criteria
Exclusion criteria: 1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, sleep apnea syndrome, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage as part of their daily intake 5. Subjects regularly taking medications (including herbal medicines) and supplements 6. Subjects allergic to medications and/or the test-food-related products 7. Subjects who are pregnant, lactating, or intending to become pregnant 8. Subjects who live with their infants less than 1 year old 9. Subjects who co-sleep with their children (1 to 6 years old) 10. Subjects who live with requiring long-term care persons 11. Subjects who share the bed with more than one person 12. Subjects who work late-night shift and the life-styles are irregular 13. Subjects who wake up for urination three 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 invitation to participate in this trial, or plan to participate in another trial during this trial 18. Subjects who are judged by the physician as ineligible to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values on scores for each category of OSA sleep inventory MA version (OSA-MA; five categories) at four weeks after the start of test-food consumption (4w) 2. The measured values on scores for each item of OSA-MA (16 items) at 4w 3. The measured values of subjective symptom scores based on the VAS item scores at 4w 4. The measured values of work efficiency test (Advanced Trail Making Test; ATMT) at 4w | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed