Healthy Japanese
Conditions
Interventions
Duration: 53 weeks Test food: Food containing lactic acid bacteria Administration: Take one tablet once a day
Duration: 53 weeks Test food: Food not containing lactic acid bacteria Administratio
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Individuals aged 40 or more and less than 70 3. Women 4. Healthy individuals 5. Individuals who have not had date of menstrual onset for at least one year 6. Individuals whose YAM score of bone density in total amount of frontal lumbar vertebra and femur are more than 70%
Exclusion criteria
Exclusion criteria: Individuals who/whose 1. have osteoporosis 2. have taken medications for osteoporosis 3. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 4. have a pacemaker or an implantable cardioverter defibrillator (ICD) 5. are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 6. receive hormonal therapy 7. are heavy smokers (generally smoking 21 cigarettes or more per day) 8. regularly drink alcohol {generally drinking 60 g/day as absolute alcohol (about 3 go of sake, 3 medium bottles (1,500 mL) of beer, 2 go of shochu, just under 5 glasses (600 mL) of wine) at least six days a week} 9. have extremely irregular eating habits or irregular lifestyles by shift work, night work, or other reasons 10. living environment (e.g., family, or work) may major changes (e.g., relocation, work transfer, or long-term travel), or eating or exercise habits may major changes during this study 11. take "Foods for Specified Health Uses", "Foods with Functional Claims", or "Food with Nutrient Function Claims" (particularly those containing calcium, vitamin D or K, magnesium, isoflavones (including daidzein, genistein, or equol), lactic acid bacteria other than test food, or others which affect bone metabolism) 12. are taking or using medications (including herbal medicines) and supplements 13. are allergic to medicines and foods related to the test product 14. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 15. are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of bone density of total amount of frontal lumbar vertebra at 53 weeks after consumption (53w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of bone density of total amount of frontal lumbar vertebra at 27 weeks after consumption (27w) 2. The amount and percentage of change of bone density of total amount of frontal lumbar vertebra from screening (before consumption; Scr) to 27w and 53w 3. The measured values of each item (bone area, bone mineral content, T-score, young adult mean (YAM) score, Z score) of total amount of frontal lumbar vertebra at 27w and 53w, and the amount and percentage of changes of them from Scr 4. The measured values of each item (bone area, bone mineral content, bone density, T-score, YAM score, Z score) of frontal lumbar vertebra (L2, L3, L4) at 27w and 53w, and the amount and percentage of changes of them from Scr 5. The measured values of each item (bone area, bone mineral content, bone density, T-score, YAM score, Z score) of left femur (neck, trochanter, inter, total amount) at 27w and 53w, and the amount and percentage of changes of them from Scr 6. The measured values of simplified menopausal index (SMI) score, grip strength, acetic acid, propionic acid, iso-butyric acid, n-butyric acid, iso-valeric acid, n-valeric acid, lactic acid, succinic acid, formic acid, body weight, body mass index (BMI), body fat percentage, lean body mass, and appendicular skeletal muscle mass at 27w and 53w 7. The measured values of cross-linked N-telopeptide of type I collagen (NTx), osteocalcin (OC), bone-specific alkaline phosphatase (BAP), total type I procollagen-N-propeptide (total P1NP), and tartrate-resistant acid phosphatase 5b (TRACP-5b) corrected for urea-creatinine at 27w and 53w, and the amount and percentage of changes of them from Scr 8. Individuals whose responses to an original questionnaire improved by one or more scales at 27w and 53w compared to Scr | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed