A verification study of the improving effect on bone metabolism

Not Applicable

• Conditions: Healthy Japanese subjects

• Registration Number: JPRN-UMIN000051048
• Lead Sponsor: ORTHOMEDICO Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-12
• Study Completion: 2023-10-01
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)