Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Tablet containing Bacillus subtilis C-3102 spores Administration: Take three tablets with a proper amount of water without chewing after breakfast once daily *If you
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy subjects 5. Subjects who are judged in the Kellgren-Lawrence grade (KL grade) either 0 or 1 in X-ray at screening (before consumption; Scr) 6. Subjects whose score of the JKOM is high at Scr
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 are allergic to medicines and/or the test food related products (particularly soy, or natto) 7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The Japanese Knee Osteoarthritis Measure (JKOM) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The Japanese Knee injury and Osteoarthritis Outcome Score (J-KOOS) 2. Body fat percentage, fat mass, lean mass, muscle mass, and body water 3. The number of times of standing up from the chair for 30 seconds | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed