Healthy adults
Conditions
Interventions
Duration: 24 weeks Test materials: Maltobionic acid containing corn syrup solid (Oligo-sugar acid of calcium) Dose: 2 packs, once a day (8 g) Administration: Take 2 packs after meal with water, war
Sponsors
ORTHOMEDICO Inc.
Seishin-kai Medical Association Inc, Takara Medical Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese adult females 2. Those who are menopause for at least 1 year 3. Those who had no abnormity in screening urinalysis 4. Those who have 72-100% of YAM score of femoral neck fracture and lumbar spine total amount at screening and examination before ingestion. Select criteria are that those who have closer to 72% of YAM score of either femoral neck fracture or lumbar spine total amount. In case of the selected number small the sample size, select one of closer to 100%.
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Currently taking medicines and/or herbal medicines 4. Those who use or take "Foods for Specified Health Uses" and "Foods with Functional Claims" in daily 5. Those who take "Foods for Specified Health Uses," "Foods with Functional Claims," or supplements; calcium, vitamin D, vitamin K, magnesium, isoflavones, (included Daidzein, genistein, Equol and etc.) related to bone metabolism more than once a week 6. Those who are allergic to medicines and/or the test food related products 7. Those who had participated another clinical test for three months when you signed the informed consent form for this trial 8. Others consider as inappropriate for this test by the doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Dual Energy X-ray Absorptiometry (DEXA) Left femoral neck fracture: Bone area, bone mineral density, bone density ,T-score, YAM score, Z score Lumbar spine total amount: Bone area, bone mineral density, bone density ,T-score, YAM score, Z score | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Peripheral blood test TRACP-5b, OC, BAP 2. Subjective symptoms Questionnaire of physical and life related to osteoporosis | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed