An interventional study of Placebo and Nuvicol II in Osteoarthritis, Knee, sponsored by Universidad Católica San Antonio de Murcia. Recruiting at 1 site in Spain. Open to participants aged 31 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Universidad Católica San Antonio de Murcia · Not applicable, Interventional, and Treatment
This randomized, controlled, double-blind, three-arm parallel clinical trial will evaluate the efficacy and safety of undenatured type II collagen products on joint pain in adults diagnosed with knee osteoarthritis. Participants will be randomized to Nuvicol II (nuvicol® II), Nuvicol SII (nuvicol® S II), or placebo and will consume one capsule daily for 4 months. Pain, quality of life, knee muscle function, concomitant analgesic medication use, cartilage degradation biomarkers, safety laboratory variables, and adverse events will be assessed during follow-up.
Participants diagnosed with osteoarthritis and persistent knee pain will be randomized in equal proportion to one of three parallel arms: Nuvicol II (nuvicol® II), Nuvicol SII (nuvicol® S II), or placebo. The study product will be consumed once daily for 4 months. Assessments include baseline laboratory visits, home controls at approximately 30 and 90 days, an intermediate visit at approximately 60 days, and a final visit at approximately 120 days. The primary efficacy assessment is joint pain measured with a visual analog scale. Secondary assessments include KOOS and WOMAC questionnaires, concomitant analgesic medication use, knee muscle function by isometric and isokinetic dynamometry, biomarkers of cartilage degradation, blood safety analysis, and adverse events.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's planned enrollment of 120 is above the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Universidad Católica San Antonio de Murcia is the lead sponsor of 138 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Participants receive Nuvicol II (nuvicol® II), undenatured type II collagen from chicken source, 40 mg once daily for 4 months.
Dietary Supplement: Nuvicol II
Participants receive Nuvicol SII (nuvicol® S II), undenatured type II collagen from salmon source, 40 mg once daily for 4 months.
Dietary Supplement: Nuvicol SII
Participants receive matching placebo capsules containing maltodextrin and magnesium stearate once daily for 4 months.
Dietary Supplement: Placebo
Matching placebo capsules containing maltodextrin and magnesium stearate, orally once daily for 4 months.
Undenatured type II collagen from chicken source, 40 mg orally once daily for 4 months.
Also known as: nuvicol® II
Undenatured type II collagen from salmon source, 40 mg orally once daily for 4 months.
Also known as: nuvicol® S II
Change in joint pain intensity measured by visual analog scale
Joint pain intensity will be measured using a 10-cm visual analog scale. The participant marks pain intensity from 0, no pain, to 10, worst imaginable pain. The primary endpoint is change from baseline in VAS pain score.
Time frame: Baseline to 16 weeks
Change in knee-related quality of life measured by KOOS
KOOS evaluates pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. Scores are transformed to a 0 to 100 scale, where 0 represents extreme knee problems and 100 represents no knee problems.
Time frame: Baseline to 16 weeks; also assessed at 30, 60, and 90 days
Change in pain, stiffness, and physical function measured by the Western Ontario and McMaster Universities Osteoarthritis Index
The Western Ontario and McMaster Universities Osteoarthritis Index assesses pain, stiffness, and physical function in participants with knee osteoarthritis. The total score ranges from 0 to 96, with higher scores indicating worse symptoms and physical function.
Time frame: Baseline to 16 weeks; also assessed at 30, 60, and 90 days
Change in concomitant analgesic medication use
Daily prescribed and rescue analgesic medication use will be recorded to evaluate changes in the need for analgesic medication.
Time frame: Baseline to 16 weeks
Change in knee muscle function by dynamometry
Isometric and isokinetic knee muscle function will be measured with a Biodex System 3 dynamometer in the painful knee, including extension and flexion assessments.
Time frame: Baseline, 8 weeks, and 16 weeks
Change in serum cartilage oligomeric matrix protein concentration
Serum cartilage oligomeric matrix protein concentration will be assessed as a biomarker of cartilage degradation and cartilage catabolism.
Time frame: Baseline, 8 weeks, and 16 weeks
Change in renal and hepatic blood safety parameters
Biochemical and hematological blood analyses will be used to evaluate renal and hepatic safety parameters during the study.
Time frame: Baseline to 16 weeks
Change in urinary C-terminal telopeptide of type II collagen concentration
Urinary C-terminal telopeptide of type II collagen concentration will be assessed as a biomarker of cartilage degradation and treatment response.
Time frame: Baseline, 8 weeks, and 16 weeks
Incidence of adverse events
Adverse events will be collected throughout the study to assess product safety.
Time frame: Baseline to 16 weeks
Plan to share: No — Individual participant data will not be shared because study data will be coded and managed according to confidentiality and data protection requirements.
Start is estimated for Mar 2027; primary completion for Jul 2027, 4 months later.
Of 1,143 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 4 months is below that.
Counting every sponsor, half of 1,285 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Universidad Católica San Antonio de Murcia →