Healthy Japanese
Conditions
Interventions
Duration: 24 weeks Test product: Test food Administration: Three capsules/pack/day
Duration: 24 weeks Test product: Placebo food Administration: Three capsules/pack/day
Sponsors
Euglena Co., Ltd.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Women 3. Adults 4. Healthy participants 5. Participants who are menopause for at least one year 6. Participants who have 70% or more young adult mean (YAM) values bone density of lumbar vertebra (total amount)
Exclusion criteria
Exclusion criteria: Participants who 1. have osteoporosis 2. have taken medicines for osteoporosis 3. are undergoing treatment or have a history of malignant tumor, heart failure, or myocardial infarction 4. have a pacemaker or an implantable cardioverter defibrillator 5. are undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 6. receive hormonal therapy 7. are heavy smokers (generally smoking 21 or more cigarettes per day) 8. consume excessive alcohol {generally drinking 60 g or more of pure alcohol per day (3 go of sake, 3 medium bottles of beer (1,500 mL), 2 go of shochu, or about 5 glasses of wine (about 600 mL) at least 6 days per week} 9. have extremely irregular eating habits or irregular life rhythms due to shift work, late-night work, or other factors 10. may experience significant changes (e.g., relocation, job transfer, or long-term travel) in their living environment (e.g., family or work) or in their eating and exercise habits during this study 11. are taking Foods for Specified Health Uses, Foods with Functional Claims, or Food with Nutrient Function Claims (particularly those containing calcium, vitamin D or K, magnesium, isoflavones including daidzein, genistein, or equol, lactic acid bacteria other than test food, or others which affect bone metabolism) 12. are taking or using medicines (including herbal medicines) or supplements 13. are allergic to medicines or foods related to the test product 14. are taking antithrombotic drugs such as warfarin 15. are pregnant, lactating, or planning to become pregnant during this study 16. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 17. are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary bone density measurement | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary bone density measurements, urinalysis, peripheral blood tests, physical measurements, and adverse events | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed