The efficacy evaluation of proteoglycan on cartilage biomarkers in subjects with knee joints discomfort.

Not Applicable

• Conditions: Healthy volunteer

• Registration Number: JPRN-UMIN000016470
• Lead Sponsor: TTC Co., Ltd.

Brief Summary

Evaluation of the effect of salmon nasal proteoglycan on biomarkers for cartilage metabolism in individuals with knee joint discomfort: A randomized double-blind placebo-controlled clinical study. Abstract A randomized double-blind placebo-controlled clinical trial was conducted to evaluate the chondroprotective action of salmon nasal cartilage proteoglycan on joint health. The effect of oral administration of proteoglycan (10 mg/day) on cartilage metabolism was evaluated in individuals with knee joint discomfort but without diagnosis of knee osteoarthritis. The average age of patients was 52.6 +/- 1.1 years old. The effect of proteoglycan was evaluated by analyzing markers for type II collagen degradation (C1,2C) and synthesis (PIICP), and the ratio of type II collagen degradation to synthesis. The results indicated that the change in C1,2C levels significantly differed in the proteoglycan group compared with the placebo group following 16 weeks intervention among subjects with high levels of knee pain and physical dysfunction (total score of Japan Knee Osteoarthritis Measure more than 41) and subjects with constant knee pain (both P<0.05). There was a greater increase in PIICP levels in the proteoglycan group than the placebo group following intervention, although this difference was not significant in both sets of patients. Thus, the C1,2C/PIICP ratios decreased in the proteoglycan group, whereas they slightly increased in the placebo group following the intervention. Furthermore, no test supplement-related adverse events were observed during the intervention. Therefore, oral administration of salmon nasal cartilage proteoglycan at a dose of 10 mg/day may exert a chondroprotective action in subjects with knee joint discomfort. This effect was achieved by improving cartilage metabolism (reducing type II collagen degradation and enhancing type II collagen synthesis), without causing apparent adverse effects.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified