Healthy volunteer
Conditions
Interventions
Proteoglycan capsules are ingested for 16 consecutive weeks at 10mg.
Placebo capsules (no proteoglycan) are ingested for 16 consecutive weeks.
Sponsors
TTC Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females at the ages of 35 to 75 2. Subjects who confirmed pain of knee joint by JKOM and VAS. 3. Subjects who are classified into 0-II grade on the basis of the Kellgren-Lawrence classification. (Subjects who undiagnosed with Knee Osteoarthritis by physician)
Exclusion criteria
Exclusion criteria: 1. Subjects who exceeded the value of knee pain more than the sum VAS value of other joint pain 2. Subjects who are confirmed 30-points by JOA score, the degree of knee pain and walk ability 3. Subjects who are suspected gouty attack with hyperuricemia 4. Subjects who have positive rheumatoid factors on the screening test or may have rheumatic pain 5. Subjects who have performed arthroplasty or need it 6. Subjects who regularly take health food containing proteoglycan or related to bone and joint wellness from three month before the screening test to the end of the study 7. Subjects who regularly take medicine, except in the case of permission to take anti-pain and anti-inflammatory drug by physician 8. Subjects who take medicine more than three days a week or plan to do them in study period 9. Subjects who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test 10. Subjects who get an intense exercise to make excessive load on the joints 11. Subjects who have a history of the disorder related to bone and joint such as fracture and sprain within a year before the screening test 12. Subjects who get a diagnosis of malignancy, are under treatment for hypertension, cardiac disease, renal disease and thyroid dysfunction, and have a history of serious disorder such as hepatic disease 13. Subjects who consume an excess amounts of alcohol 14. Subjects who have possibility of allergy symptoms onset by the raw material in test diet 15. Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire 16. Subjects who take warfarin 17. Subjects who have participated in other clinical study within a month before the screening test or who intend to participate in study period 18. Subjects who intend to become pregnant or lactating 19. Subjects who are judged as unsuitable for this study by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C2C, PIICP, CTX-II, CTX-II/PIICP, C1,2C, CS846, COMP, C1,2C/PIICP | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale (VAS), Japanese Knee Osteoarthritis Measure (JKOM), Japanese Orthopaedic Association score (JOA score) | — |
Countries
Japan
Contacts
Public ContactTakashi Nakagawa
TTC Co., Ltd. Clinical Research Planning Department
Outcome results
None listed