Healthy Japanese subjects
Conditions
Interventions
Duration: Six months Test food: Capsule containing lactic acid bacteria Administration: Take one capsule per day with water *If you forget to take the test food, take it as soon as you remember.
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 40 or more and less than 80 4. Subjects whose right, left, and left/right average of the pure tone average (calculated by one-fourth method) are all 24 dB or less 5. Subjects whose difference in the pure tone average (calculated by one-fourth method) between left and right ear is within 20 dB 6. Subjects whose either value of the distortion product otoacoustic emissions (DPOAE) measured at right, left, or as an average of left and right is -10 dBSPL or more at 500 Hz, 1000 Hz, or 2000 Hz, and whose value measured at right, left, or as an average of left and right is 0 dBSPL or less at 8000 Hz 7. Subjects whose minimum audible threshold of right, left, or left/right average measured at frequency of 8,000 Hz meet any of the following conditions (i~xiv) i. Men aged 40 to 49: >= 12 dB ii. Women aged 40 to 49: >= 10 dB iii. Men aged 50 to 54: >= 19 dB iv. Women aged 50 to 54: >= 14 dB v. Men aged 55 to 59: >= 23 dB vi. Women aged 55 to 59: >= 17 dB vii. Men aged 60 to 64: >= 30 dB viii. Women aged 60 to 64: >= 22 dB ix. Men aged 65 to 69: >= 38 dB x. Women aged 65 to 69: >= 30 dB xi. Men aged 70 to 74: >= 44 dB xii. Women aged 70 to 74: >= 40 dB xiii. Men aged 75 to 79: >= 53 dB xiv. Women aged 75 to 79: >= 49 dB
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, neurological disease, insomnia, sleep disorder, labyrinth disease, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or "Foods with Nutrient Function Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines), internal quasi-drugs, or supplements 6. Subjects who drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 7. Subjects who have a smoking habit 8. Subjects who have difficulty maintaining a constant lifestyle during this trial, such as those who plan to make significant changes in their lifestyle (such as diet, sleep, and exercise), work night shifts or other rotating shifts, or plan to travel abroad 9. Subjects who have not been getting enough sleep 10. Subjects who have constipation 11. Subjects who are allergic to medicines and/or the test food related products 12. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 13. Subjects who suffer from COVID-19 14. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 15. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Minimum audible threshold at six months after consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Minimum audible threshold at two months and four months after consumption 2. Otoacoustic emission levels and the Japanese Version of the Hearing Handicap Inventory for Adults (HHIA) (emotional subscale, social subscale, and each item) at two, four, and six months after consumption | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed