Healthy Japanese adult people
Conditions
Interventions
Duration: 24 weeks Test materials: Corn syrup containing maltobionic acid Dose: 7 g/day Administration: Take it during or after meal with water, carbonated water, milk, or apple juice, even with s
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese adult female 2. Subjects who are menopause (natural menopause) for at least 1 year 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects who have 70% or more but less than 100% in total amount of lumbar vertebra (the mean in young adults) of YAM score at screening and examination before consuming. If number of subjects who passed the inclusion criteria is below the sample size, select them whose YAM scores are closer to 100%
Exclusion criteria
Exclusion criteria: 1. A medical history of malignant tumor, heart failure or myocardial infarction 2. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3. Subjects who take supplements, "Foods for Specified Health Uses," "Foods with Functional Claims," or "Foods with Nutrient Function Claims" related to bone metabolism, such as calcium, vitamin D, vitamin K, magnesium, isoflavones, (included daidzein, genistein, equol, or etc.), more than once a week 4. Currently taking medications (include herbal medicines), "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage 5. Subjects who are allergic to medicines and/or the test food related products 6. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 7. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone density of total amount of lumbar vertebra * Measured by Dual Energy X-ray Absorptiometry (DEXA) * Perform the test at screening and examination before consuming and at 12 and 24 weeks after ingestion | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Left femur (thigh bone) (neck, trochanter, inter, total amount, and Ward' s): Bone area, bone mineral density, bone density, T-score, YAM score, and Z score 2. Lumbar vertebra (L2, L3, L4, and total amount): Bone area, bone mineral density, T-score, YAM score, and Z score 3. Peripheral blood test Tartrate-resistant Acid Phosphatase 5b (TRACP-5b), osteocalcin (OC), bone specific alkaline phosphatase (BAP), crosslinked N-telopeptide of type I collagen (NTx) 4. Urinalysis Crosslinked N-telopeptide of type I collagen (NTx), deoxypyridinoline (DPD) 5. Subjective symptoms Questionnaire of physical and life related to osteoporosis *1,2 Measured by Dual Energy X-ray Absorptiometry (DEXA) *1-5 Perform the tests at screening and examination before consuming and at 12 and 24 weeks after ingestion | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed