None listed
Conditions
Interventions
Dietary Supplement : Osteo-F or placebo
500mg per tablet, 1 tablet once a day, oral administration for 24 weeks
Sponsors
BOIN BIO Convergence
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Menopausal women over 45 years of age 2) A woman who do not take menopause-related drugs or estrogen 3) A person who agrees to participate in the study voluntarily and sign the informed consents
Exclusion criteria
Exclusion criteria: 1) A person who diagnosed with or undergoing treatment for osteoporosis 2) A person who suffering from diseases that affect bone metabolism (thyroid or parathyroid disease, Cushing's syndrome, diabetes, kidney disease, ovarian cancer, etc.) 3) A person who has received hormone replacement therapy (steroids, female hormones, thyroid hormones) within the last 3 months 4) A person who has continuously taken osteoporosis-related Western medicines, herbal medicines, or bone health-related health functional foods (calcium, vitamin D preparations, etc.) within the last 3 months 5) Patients with uncontrolled high blood pressure despite taking medication 6) Underweight or Obesity (BMI < 18.5 kg/m2 or BMI = 30.0 kg/m2) 7) A person who has a history of vertebral compression fractures or who have had spinal surgery 8) Rheumatoid disease, asthma, AIDS patients 9) Respiratory disease (chronic obstructive pulmonary disease), heart disease, chronic renal failure 10) A person who has gallbladder disease or gastrointestinal disease (gastrectomy, inflammatory bowel disease, malabsorption), gout, or porphyria 11) A persons with mental disorders such as schizophrenia, alcoholism, and drug addiction 12) Renal dysfunction (creatinine rise more than 1.5 times the upper limit of normal), liver dysfunction (increase of more than 2.5 times the upper limit of normal for AST and ALT), malignancy, and other diseases that the investigator considers inappropriate for this study 13) A person with allergy or hypersensitivity to ingredients of investigational product. 14) A person who have been diagnosed with or treated for cancer within the past 5 years 15) A person who have had surgery within the last 6 months 16) A person who has participated in other clinical studies within 1 month prior to the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dual-energy X-ray absorptiometry(DXA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone health related indicators(Osteocalcin, Calcium, Phosphorus, ALP, Bone-specific alkaline Phosphatase(BSALP), C-terminal telopeptide of type 1collagen, Vitamin D, parathyroid hormone(PTH));Muscle function related indicators(hand grip,skeletal muscle index(SMI), Skeletal muscle mass, Appendicular skeletal muscle mass(ASM)/weight * 100);Muscle function related blood indicators( Creatinine, Creatine Kinase(CK), Lactate dehydrogenase(LDH)) | — |
Countries
Korea, Republic of
Contacts
Public ContactBok Minkyung
Research Institute of Medical Nutrition
Outcome results
None listed