Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Kinkoichiro Administration: Take seven tablets any time during the day with water * Daily dose should be taken within the day. If you forget to take the test food,
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 aware of the discomfort of the knee joint 6. Subjects who are judged as eligible to participate in the study by the physician 7. Within the subjects who met the sixth inclusion criteria, subjects who are judged in the Kellgren-Lawrence grade (KL grade) either 0 or 1 in X-ray at Scr 8. Within the subjects who met the seventh inclusion criteria, subjects whose JKOM score are high at Scr
Exclusion criteria
Exclusion criteria: 1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who are undergoing or need to undergo treatment for knee disease such as knee osteoarthritis 4. Subjects who have lactose intolerance 5. Subjects who have undergone or need to undergo knee surgery 6. Subjects who may experience rheumatic pain 7. Subjects who are attending an orthopedic or osteopathic clinic 8. Subjects who are intensely exercising to make excessive load on the body 9. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, bronchial asthma, hypercalcemia, histoplasmosis, hyperparathyroidism, sarcoidosis, lymphoma, tuberculosis, or other chronic diseases 10. Subjects who use antiplatelet agent 11. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily 12. Subjects currently taking medicines (include herbal medicines) and supplements 13. Subjects who are allergic to medications and/or the test-food-related products (particularly milk, fish, egg, or chicken) 14. Subjects who are pregnant, breast-feeding, and planning to become pregnant 15. Subjects who suffer from COVID-19 16. 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 17. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values of the score of Japanese Knee Osteoarthritis Measure (JKOM) at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of the score of JKOM at four and eight weeks after consumption (4w, 8w) 2. The amounts of changes of the score of JKOM from screening (before consumption; Scr) at 4w, 8w, and 12w 3. The measured values and amount of change from Scr in each of the following items at 4w, 8w, and 12w: visual analogue scale (VAS), the scores of pain and stiffness in knees, conditions in daily life, general activities, and health conditions, individual items of the JKOM questionnaire, deoxypyridinoline (DPD), bone specific alkaline phosphatase (BAP), crosslinked N-telopeptide of type I collagen (NTx), tartrate-resistant acid phosphatase 5b (TRACP-5b), and high sensitivity C-reactive protein (CRP) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed