Healthy Japanese subjects
Conditions
Interventions
Duration: 24 weeks Test food: Active food 1 Administration: Take one pack with water after breakfast * Daily dose should be taken within the day. If you forget to take the test food, take it as s
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. Subjects aged 20 or more and less than 65 3. Female 4. Healthy 5. Subjects who have not had menses for more than one year and are considered to be menopause 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects who have 70% or more YAM values in total amount of lumbar vertebra at Scr
Exclusion criteria
Exclusion criteria: 1. Subjects who are osteoporosis (YAM score of total amount of lumbar vertebra is less than 70%) 2. Subjects who have taken medications for osteoporosis 3. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 4. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 5. Subjects currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 6. Subjects who receive hormonal therapy 7. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 8. Subjects who take supplements, "Foods for Specified Health Uses", "Foods with Functional Claims", or "Food with Nutrient Function Claims" which may influence bone metabolism such as calcium, vitamin D or K, magnesium, lactic acid bacteria, or isoflavones (including daidzein, genistein, or equol) in daily use 9. Subjects currently taking medicines (include herbal medicines) and supplements 10. Subjects who are allergic to medications and/or the test-food-related products 11. Subjects who suffer from COVID-19 12. 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 13. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values of bone density of total amount of lumbar vertebra at 24 weeks after the consumption (24w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of bone density of total amount of lumbar vertebra at 12 weeks after the consumption (12w) 2. The measured values of each item of total amount of lumbar vertebra {bone area, bone mineral density, T-score, Young Adult Mean (YAM) score, and Z score} at 12w and 24w 3. The amount of change of each item of total amount of lumbar vertebra (bone area, bone mineral density, bone density, T-score, YAM score, and Z score) from screening (before consumption; Scr) at 12w, and 24w 4. The measured values and amount of change from Scr in each of the following items at 12w, and 24w: each item of lumbar vertebra (L2, L3, L4) (bone area, bone mineral density, bone density, T-score, YAM score, and Z score), left femur (neck, trochanter,and total amount) (bone area, bone mineral density, bone density, T-score, YAM score, and Z score), blood test {osteocalcin (OC), bone-specific alkaline phosphatase (BAP), total type I procollagen-N-propeptide (total P1NP), cross-linked N-telopeptide of type I collagen (NTx), cross-linked C-telopeptide of type I collagen (CTx), and tartrate-resistant acid phosphatase 5b (TRACP-5b)}, and urinalysis {deoxypyridinoline (DPD) and pentosidine} | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed