None listed
Conditions
Interventions
12-week intake of active food (high dose)
12-week intake of active food (low dose)
12-week intake of placebo food
Sponsors
Meiji Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged over 50 years old and who are from 1 year to 10 year after menopause when consent acquisition 2. Subjects with a BMI of 18.5 or more and less than 30. 3. Subjects giving informed consent
Exclusion criteria
Exclusion criteria: 1.Subjects with food allergies 2.Subjects with lactose intolerance 3.Subjects who have menopause before 43 years old 4.Subjects who have been diagnosed with osteoporosis 5.Subjects who have undergone bilateral oophorectomy 6.Subjects who suffer from serious disorders of liver, kidney, heart, lung, or digestive organs (including gastric resection), diabetes, rheumatoid arthritis, neurological/mental diseases, endocrine diseases, or other serious and/or progressive diseases. 7.Subjects who have been diagnosed with congenital bone metabolism diseases (osteogenesis imperfecta, Marfan syndrome, etc.) 8.Subjects who have a history of bone fracture within the past year 9.Subjects who have been receiving long-term medical treatment (hospitalization, etc.) within the past year. 10.Subjects currently receiving medicine treatment known to affect bone metabolism (hormone therapy, steroids (last 6 months), warfarin, SSRI, anticonvulsants, methotrexate, heparin, beta-blockers, alpha-blockers, alpha, beta-blockers, etc.) 11.Heavy drinkers (weekly average of 30 g/day or more of pure alcohol) 12.Smoker 13.Subjects who regularly use medicines, health foods or supplements that may affect this study (e.g. intestinal regulators, calcium, magnesium, vitamin D, vitamin K, soy isoflavone, foods/beverages/supplements containing lactic acid bacteria (e.g. yogurt), foods/beverages/supplements containing prebiotics such as oligosaccharides , etc.) 14.Subjects with severe vitamin D deficiency (serum 25-OH-vitamin D less than 10 ng/ml) 15.Subjects who participate in other clinical trials within the past 3 months or have plans to participate in other clinical trials during this study period 16.Subjects who determine ineligible by the principal investigator or the co-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone resorption markers | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone formation markers, cartilage degradation markers, urinary amino acids(a marker of muscle protein breakdown, etc.), serum cytokines, biomarker of intestinal barrier function, microbiome, JKOM, grip strength, body composition, bone mass (Quantitative ultrasound (QUS) of the calcaneus), self-assessment table for calcium intake, VDDQ-J, and simple vitamin K intake questionnaire | — |
Countries
Japan
Contacts
Public ContactSatoshi Takasugi
Meiji Co., Ltd. R&D Division
Outcome results
None listed