None listed
Conditions
Interventions
Dietary Supplement : Test group: 1 capsule once daily, 130 mg/day (containing 40 mg/day of undenatured type II collagen), 12-week intake
Control group: 1 capsule once daily, 130 mg/day (without undena
Sponsors
Songwon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Subjects must meet all of the following criteria to be eligible for enrollment: 1. Adult men and women aged 40 to 75 years (inclusive) 2. Subjects with a knee Kellgren-Lawrence (KL) grade of I or II 3. Subjects with a Visual Analog Scale (VAS) score between 30 and 100 mm 4. Subjects with a Body Mass Index (BMI) of 18.5 to 29.9 kg/m² 5. Subjects who complain of knee discomfort associated with exercise or physical activity at any time during the 2 weeks prior to screening 6. Subjects who provided written informed consent to comply with this study and voluntarily decided to participate
Exclusion criteria
Exclusion criteria: ? Subjects may be excluded if any of the following apply: 1. Subjects with a history of drug abuse or substance dependence 2. Subjects who have used glucosamine sulfate, chondroitin sulfate, intra-articular hyaluronate, systemic glucocorticoids, or intra-articular glucocorticoids within 3 months prior to the date of informed consent 3. Subjects who have taken anti-inflammatory drugs, Boswellia, curcumin, omega-3 fatty acids, or collagen supplements within 30 days prior to the date of informed consent, or who are chronic users of such products 4. Subjects diagnosed with an inflammatory joint disorder according to the criteria of the American College of Rheumatology (ACR) 5. Subjects with moderate to severe synovitis (Kellgren–Lawrence Grade III or higher) 6. Subjects with a meniscal tear 7. Subjects with chronic renal, hepatic, gastrointestinal, cardiovascular, endocrine, or neurological diseases 8. Subjects with a history of knee or hip replacement surgery 9. Pregnant or breastfeeding subjects, or subjects planning to become pregnant during the study period 10. Subjects with a known allergy or adverse reaction to the investigational product 11. Subjects with excessive alcohol consumption (men = 40 g/day; women = 20 g/day, based on the WHO daily alcohol consumption criteria) 12. Heavy smokers (= 20 cigarettes per day) 13. Subjects who have taken joint health-related dietary supplements within 3 months prior to the date of informed consent 14. Subjects who have participated in another clinical study within 3 months prior to the date of informed consent 15. Subjects who, in the opinion of the Principal Investigator, are considered unsuitable for participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index_total score;Western Ontario and McMaster Universities Osteoarthritis Index_subcategory score;Visual Analog Scale(VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| World Health Organization Quality of Life Brief Version(WHOQOL-BREF);Lequesne Functional Index;high-sensitivity C-Reactive Protein(hs-CRP), Erythrocyte Sedimentation Rate(ESR), Tumor Necrosis Factor-alpha(TNF-a), Interleukin-1 beta(IL-1ß);Cartilage Oligomeric Matrix Protein, Matrix Metalloproteinase-2, C-Terminal Telopeptide of Type II Collagen;Clinical Laboratory Test;Vital Signs;Adverse Event | — |
Countries
Korea, Republic of
Contacts
Public ContactSeong-Bong Hong
Songwon University
Outcome results
None listed