Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Capsule containing lactic acid bacteria, Lactococcus lactis subsp. Cremoris H61 strain Administration: Take one capsule per day with water after breakfast. *If you f
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Women 3. Adults 4. Healthy subjects 5. Subjects who have been postmenopausal (natural menopause) for at least one year in self-knowledge
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who take foods containing lactic acid bacteria (e.g. yogurt) at least three times a week 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who suffer from COVID-19 9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who are judged as ineligible to participate in this study by the physician 11. Subjects who usually take foods/beverages containing lactic acid bacteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values of following items at 12 weeks after consumption: cross-linked N-telopeptide of type I collagen (NTx), tartrate-resistant acid phosphatase 5b (TRACP-5b), bone-specific alkaline phosphatase (BAP), type I procollagen-N-propeptide (P1NP), and osteocalcin (OC) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed