Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Tablet containing salmon nasal cartilage-derived proteoglycan Administration: Take one tablet after dinner with water * Daily dose should be taken within the day. If
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. Male or female 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects who are judged in the Kellgren-Lawrence grade (KL grade) either 0 or 1 in X-ray 7. Subjects whose measured values of P2CP is relatively low
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 disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 5. Subjects currently taking medicines (include herbal medicines) and supplements 6. Subjects who are allergic to medications and/or the test-food-related products 7. Subjects who are pregnant, breast-feeding, and planning to become pregnant 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 the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured values and amount of change from before consumption (Scr) in each of the following items at four, eight and twelve weeks after consumption (4, 8 and 12w): Procollagen II C-Terminal Propeptide (P2CP), Coll2-1*, Cartilage origomeric matrix protein (COPM), Collagen Type II Cleavage (C2C), and C-terminal telopeptides of type II collagen (CTx) *Due to the outbreak of COVID-19 infection, the measurement of the originally planned marker is no longer feasible and thereby the measuring marker has been changed. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Due to the outbreak of COVID-19 infection, the originally planned step test is no longer feasible and thereby has been removed. | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed