Effects of Different Collagen Formulations on Knee Osteoarthritis
Comparison of the Effects of Different Collagen Formulations on Pain, Function, and Quality of Life in Patients With Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
1 other identifier
interventional
45
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2026
CompletedFirst Posted
Study publicly available on registry
September 2, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
September 2, 2026
August 1, 2026
7 months
August 30, 2026
August 30, 2026
Conditions
Keywords
Outcome Measures
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.
Baseline (Week 0) and End of Intervention (Week 8)
Secondary Outcomes (3)
Change in Visual Analog Scale (VAS) for Pain
Baseline (Week 0) and End of Intervention (Week 8)
Change in Central Sensitization Inventory (CSI) Score
Baseline (Week 0) and End of Intervention (Week 8)
Change in Intermittent and Constant Osteoarthritis Pain (ICOAP) Questionnaire Score
Baseline (Week 0) and End of Intervention (Week 8)
Study Arms (3)
Hydrolyzed Collagen
EXPERIMENTALParticipants in this arm will receive a daily single-use sachet containing 10 grams of enzymatically hydrolyzed bovine collagen peptide. The supplement is to be dissolved in water and consumed once daily for 8 weeks.
Bioactive Collagen Peptide
EXPERIMENTALParticipants in this arm will receive a daily single-use sachet containing 5 grams of lower molecular weight bovine collagen peptide mixed with 5 grams of maltodextrin. The supplement is to be dissolved in water and consumed once daily for 8 weeks.
Placebo
PLACEBO COMPARATORParticipants in this arm will receive a daily single-use sachet containing 10 grams of maltodextrin, with no active collagen or protein. The placebo is completely identical to the active supplements in appearance, color, smell, and taste. It is to be dissolved in water and consumed once daily for 8 weeks.
Interventions
A 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.
A 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.
A 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.
Eligibility Criteria
You may qualify if:
- 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.
- Willingness to refrain from starting any new dietary supplements or physical therapy programs during the 8-week study period.
- Ability to read, understand, and provide written informed consent, as well as independently complete the patient-reported outcome questionnaires.
You may not qualify if:
- 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.
- Presence of systemic inflammatory joint diseases (e.g., rheumatoid arthritis, ankylosing spondylitis, gout).
- Known allergy, hypersensitivity, or intolerance to bovine (beef) products or maltodextrin.
- Current pregnancy or lactation.
- Severe neurological, psychiatric, or cognitive disorders that would prevent accurate completion of the pain and central sensitization questionnaires.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cihangir Türemişlead
Study Sites (1)
Cesme Alper Cizgenakat State Hospital
Izmir, 35950, Turkey (Türkiye)
Related Publications (4)
Sun C, Yang A, Teng F, Xia Y. Efficacy of collagen peptide supplementation on bone and muscle health: a meta-analysis. Front Nutr. 2025 Sep 18;12:1646090. doi: 10.3389/fnut.2025.1646090. eCollection 2025.
PMID: 41049371BACKGROUNDSimental-Mendia M, Ortega-Mata D, Acosta-Olivo CA, Simental-Mendia LE, Pena-Martinez VM, Vilchez-Cavazos F. Effect of collagen supplementation on knee osteoarthritis: an updated systematic review and meta-analysis of randomised controlled trials. Clin Exp Rheumatol. 2025 Jan;43(1):126-134. doi: 10.55563/clinexprheumatol/kflfr5. Epub 2024 Aug 20.
PMID: 39212129BACKGROUNDJabbari M, Barati M, Khodaei M, Babashahi M, Kalhori A, Tahmassian AH, Mosharkesh E, Arzhang P, Eini-Zinab H. Is collagen supplementation friend or foe in rheumatoid arthritis and osteoarthritis? A comprehensive systematic review. Int J Rheum Dis. 2022 Sep;25(9):973-981. doi: 10.1111/1756-185X.14382. Epub 2022 Jul 5.
PMID: 35791039BACKGROUNDGenc AS, Yilmaz AK, Anil B, Korkmaz Salkilic E, Akdemir E, Sancakli A, Mor A, Ermis E, Baraz LS, Guzel N, Kehribar L. Effect of supplementation with type 1 and type 3 collagen peptide and type 2 hydrolyzed collagen on osteoarthritis-related pain, quality of life, and physical function: A double-blind, randomized, placebo-controlled study. Jt Dis Relat Surg. 2025 Jan 2;36(1):85-96. doi: 10.52312/jdrs.2025.1965. Epub 2024 Nov 5.
PMID: 39719905BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cihangir Türemiş, Dr.
Cesme Alper Cizgenakat State Hospital, İzmir/Türkiye
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Allocation concealment will be achieved using independently coded, opaque packaging. The two active collagen interventions and the maltodextrin placebo will be formulated to be entirely identical in appearance, color, smell, taste, and volume. In addition to the roles listed above, the data analyst/statistician will also remain blinded to the group allocations until the final data analysis is complete.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Attending Surgeon
Study Record Dates
First Submitted
August 30, 2026
First Posted
September 2, 2026
Study Start
October 1, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
September 2, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Data and supporting information will become available beginning 6 months after the publication of the primary research article and ending 36 months following the publication date.
- Access Criteria
- De-identified individual participant data, study protocol, statistical analysis plan, and analytic codes will be shared with researchers who provide a methodologically sound proposal for non-commercial academic research. Proposals should be directed to the Principal Investigator via email. To gain access, data requestors will need to sign a data access agreement. Data will be provided via a secure file transfer system upon approval of the request.
De-identified individual participant data (IPD) that underlie the results reported in this article will be made available upon reasonable request to the principal investigator, following the publication of the study. Data will be shared strictly for academic and non-commercial research purposes.