Healthy Japanese
Conditions
Interventions
Duration: 16 weeks Test food: Proteoglycan derived from salmon nasal cartilage Administration: Take one tablet per day with water after dinner. *If you forget to take the test food, take it as so
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Toujinkai, Nishi-Arai Ekimae Clinic Ophthalmology and Orthopedics 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. Individuals aged 40 or more and less than 70 4. Healthy individuals 5. Individuals who are judged in the Kellgren-Lawrence grade (KL grade) as either 0 or 1 in X-ray
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently 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 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines or foods related to the test product 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who 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 9. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value and the logarithmic value of procollagen II C-terminal propeptide (P2CP) at 16 weeks after intervention (16w) 2. The measured values and the logarithmic values of P2CP at 4, 8, and 12 weeks after intervention (4w, 8w, and 12w) 3. The measured values and the logarithmic values of Coll2-1, collagen type II cleavage (C2C), cartilage oligomeric matrix protein (COMP), and creatinine-corrected C-terminal telopeptides of type II collagen (CTx-II) at 4w, 8w, 12w, and 16w | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of the Japanese Orthopaedic Association (JOA) score (left/right averaged, left leg, and right leg), pain on walking (left/right averaged, left leg, and right leg), pain on ascending or descending stairs (left/right averaged, left leg, and right leg), range of motion (left/right averaged, left leg, and right leg), joint effusion, visual analogue scale (VAS), total score of the Japanese Knee Osteoarthritis Measure (JKOM), pain and stiffness in knees, conditions in daily life, general activities, and health conditions at 4w, 8w, 12w, and 16w 2. Individuals whose responses to each item in the JKOM improved by one or more scales at 4w, 8w, 12w, and 16w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed