Effects of Different Collagen Formulations on Knee Osteoarthritis
ConditionOsteoarthritis, Knee
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-65
SponsorCihangir Türemiş
About this trial
The purpose of this study is to evaluate and compare the effects of two different collagen supplement formulations on pain, physical function, and overall quality of life in adults with knee osteoarthritis.
Knee osteoarthritis is a common joint disease characterized by cartilage degeneration, which leads to chronic pain and reduced mobility. While collagen supplements are frequently used to support joint health, their clinical effectiveness is usually measured using traditional pain scales. However, osteoarthritis pain is complex and multidimensional, often involving different patterns (such as constant or intermittent pain) and central neurological sensitization. This study aims to use a holistic approach to understand how collagen supplements affect these complex pain experiences using comprehensive patient-reported outcome measures.
Participants in this study will be adults between the ages of 35 and 65 who have been diagnosed with unilateral knee osteoarthritis (Kellgren-Lawrence grade 2 or 3).
Participants will be randomly assigned to one of three groups:
Hydrolyzed Collagen Group: Participants will consume a daily sachet containing 10 grams of enzymatically hydrolyzed bovine collagen peptide.
Bioactive Collagen Peptide Group: Participants will consume a daily sachet containing 5 grams of lower molecular weight bovine collagen peptide mixed with 5 grams of maltodextrin.
Placebo Group: Participants will consume a daily sachet containing 10 grams of maltodextrin (with no active collagen or protein), matching the active supplements in taste, smell, and appearance.
All participants will take their assigned supplement once daily for 8 weeks. To ensure unbiased results, the study is double-blind, meaning neither the participants nor the research staff evaluating the outcomes will know which group a participant is in.
Researchers will assess the participants at the beginning of the study (baseline) and at the end of the 8-week intervention. Assessments will be conducted using various established questionnaires to measure joint stiffness, physical limitations, general quality of life, and specific pain patterns, including central sensitization.
The study will be conducted at the Orthopedics and Traumatology Clinic of Cesme Alper Cizgenakat State Hospital in Türkiye. By looking beyond traditional clinical scales, this research aims to provide a deeper understanding of how different collagen formulations can improve the daily lives and complex pain symptoms of patients living with knee osteoarthritis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged between 35 and 65 years.
Clinical and radiographic diagnosis of primary knee osteoarthritis according to the American College of Rheumatology (ACR) criteria.
Radiographic severity of Kellgren-Lawrence grade 2 or 3 in the affected knee.
Experiencing chronic knee pain for at least the last 3 months.
Disqualifiers
Severe knee osteoarthritis (Kellgren-Lawrence grade 4) or mild/doubtful osteoarthritis (Kellgren-Lawrence grade 0-1).
History of intra-articular injections (corticosteroid, hyaluronic acid, PRP, stem cell, etc.) to the affected knee within the last 6 months.
Routine use of other joint health supplements (e.g., glucosamine, chondroitin, MSM, other collagen products) within the last 3 months.
History of major lower extremity surgery, major trauma, or previous ligament reconstruction (e.g., ACL reconstruction) on the affected knee.
Trial design
Design model
Parallel
Treatments tested in this trial
10g Hydrolyzed Collagen
Dietary supplementA single-use sachet containing 10 grams of enzymatically hydrolyzed bovine collagen peptide. To be dissolved in water and taken orally once daily for 8 weeks.
5g Bioactive Collagen Peptide
Dietary supplementA single-use sachet containing 5 grams of lower molecular weight bovine collagen peptide mixed with 5 grams of maltodextrin. To be dissolved in water and taken orally once daily for 8 weeks.
Placebo (Maltodextrin)
Other interventionA single-use sachet containing 10 grams of maltodextrin with no active ingredients, completely matching the active supplements in appearance, color, smell, and taste. To be taken orally once daily for 8 weeks.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Hydrolyzed CollagenExperimental treatment 1 intervention
Group B: Bioactive Collagen PeptideExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
The WOMAC is a self-administered questionnaire used to evaluate pain, stiffness, and physical function in patients with knee osteoarthritis. It consists of 24 items divided into three subscales: Pain (5 items), Stiffness (2 items), and Physical Function (17 items). The total score ranges from 0 to 96. Higher scores indicate worse symptom severity, greater pain, and more physical disability. A decrease in the score indicates an improvement in the patient's condition.
Time frame
Baseline (Week 0) and End of Intervention (Week 8)Secondary outcomes
1
Change in Visual Analog Scale (VAS) for Pain
Pain intensity will be measured using a 10-cm Visual Analog Scale (VAS). The scale is anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10). Higher scores indicate greater pain severity. A decrease in the score indicates pain relief.
Time frame
Baseline (Week 0) and End of Intervention (Week 8)2
Change in Central Sensitization Inventory (CSI) Score
The CSI is a validated screening instrument used to identify and quantify symptoms related to central sensitization. It consists of 25 items scored on a 5-point Likert scale, with a total score ranging from 0 to 100. Higher scores indicate a higher degree of central sensitization symptom severity. A decrease in the score indicates an improvement.
Time frame
Baseline (Week 0) and End of Intervention (Week 8)3
Change in Intermittent and Constant Osteoarthritis Pain (ICOAP) Questionnaire Score
The ICOAP is an 11-item questionnaire designed to comprehensively evaluate both constant and intermittent pain experiences in osteoarthritis. It provides a constant pain subscale, an intermittent pain subscale, and a total pain score. Scores are normalized to range from 0 to 100. Higher scores represent more severe constant and intermittent pain. A decrease in the score indicates symptomatic improvement.
Time frame
Baseline (Week 0) and End of Intervention (Week 8)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cihangir Türemiş
Lead sponsor
Ministry of Health, Turkey
Sponsor institution
Source ClinicalTrials.gov
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