Osteoarthritis, KneeNCT07800780
Effects of Different Collagen Formulations on Knee Osteoarthritis
A study testing 10g Hydrolyzed Collagen and 5g Bioactive Collagen Peptide in people with Osteoarthritis, Knee, run by Cihangir Türemiş at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- 10g Hydrolyzed Collagen and 5g Bioactive Collagen Peptide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Cesme Alper Cizgenakat State Hospital
Izmir, 35950
Cihangir Türemiş, Dr., +905074182484, cihangirturemis@gmail.com
Ali Kerim Yılmaz, Dr., +905424953737, akerim.yilmaz@omu.edu.tr
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
Background and Rationale Knee osteoarthritis (OA) is a prevalent joint disorder characterized by progressive cartilage degeneration, chronic pain, and loss of function. While conservative management often includes dietary supplements such as hydrolyzed collagen and bioactive collagen peptides to support joint biology, clinical evaluations of these supplements are typically limited to traditional, unidimensional pain and function scales. Recent literature, however, emphasizes that OA pain is highly complex, involving peripheral nociceptive mechanisms, constant and intermittent pain patterns, and central neurological sensitization. Addressing a significant methodological gap in the literature, this study extends beyond standard scales by incorporating comprehensive Patient-Reported Outcome Measures (PROMs) to capture the holistic pain experience, including central sensitization, in patients with knee OA.
Study Procedures and Blinding This is a single-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial. Following the baseline clinical and radiographic evaluation (Kellgren-Lawrence grading performed by an experienced orthopedic surgeon), eligible participants will be randomly allocated to one of three intervention arms using computer-assisted block randomization.
To ensure strict quadruple blinding (participant, care provider, investigator, and outcomes assessor), allocation concealment will be achieved using independently coded, opaque packaging. The active interventions (two different collagen formulations) and the placebo (maltodextrin-based) will be formulated to be entirely identical in appearance, color, smell, taste, and volume.
Intervention Administration and Monitoring Participants will be instructed to consume their assigned single-use sachet once daily between 13:00 and 15:00 for the entire 8-week intervention period. Patients will be advised to maintain their habitual physical activity levels throughout the study. Rescue analgesics are permitted if necessary for severe pain; however, the use of these medications must be strictly suspended at least 48 hours prior to any clinical evaluation session to avoid masking the outcomes. Adherence to the supplement regimen, rescue medication usage, and any potential adverse events will be continuously monitored via daily follow-up cards filled out by the participants. A minimum adherence rate of 95% is mandatory; participants failing to meet this threshold will be excluded from the final analysis.
Sample Size and Statistical Analysis Plan An a priori power analysis was conducted using G*Power software to determine the required sample size. Based on a Mixed-Design ANOVA model (group × time interaction) aiming for a moderate effect size (Cohen's f = 0.25), an alpha level of 0.05, and 80% statistical power, a minimum of 42 participants was required. To account for potential dropouts, a total of 45 patients (15 per group) will be enrolled.
Statistical analyses will be executed using R software under a Per-Protocol (PP) framework. Data normality will be assessed using the Shapiro-Wilk test. A Mixed-Design ANOVA will be employed to evaluate the main effects and the group-by-time interactions. Significant interactions will be further analyzed with post-hoc pairwise comparisons utilizing the Bonferroni correction. Effect sizes will be reported using Cohen's d for pairwise comparisons and partial eta squared (reported as η²p) for variance analyses, along with corresponding lower and upper bounds (LB/UB). Statistical significance is set at p < 0.05.
- Conditions
- Osteoarthritis, Knee
- Being tested
- 10g Hydrolyzed Collagen, 5g Bioactive Collagen Peptide, Placebo (Maltodextrin)
- Keywords
- Collagen, Dietary Supplements, Patient-Reported Outcome Measures, Central Sensitization, Osteoarthritis, Knee
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10g Hydrolyzed CollagenDietary supplement
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.
5g Bioactive Collagen PeptideDietary supplement
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.
Placebo (Maltodextrin)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Hydrolyzed Collagen | Experimental | Participants 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. Receives: Dietary Supplement: 10g Hydrolyzed Collagen |
| Bioactive Collagen Peptide | Experimental | Participants 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. Receives: Dietary Supplement: 5g Bioactive Collagen Peptide |
| Placebo | Placebo comparator | Participants 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. Receives: Other: Placebo (Maltodextrin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) and End of Intervention (Week 8)
Secondary outcomes (3)
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.
Measured: Baseline (Week 0) and End of Intervention (Week 8)
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.
Measured: Baseline (Week 0) and End of Intervention (Week 8)
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.
Measured: Baseline (Week 0) and End of Intervention (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three parallel intervention arms (Hydrolyzed Collagen, Bioactive Collagen Peptide, or Placebo) in a 1:1:1 ratio. Each participant will receive only their assigned intervention for a continuous period of 8 weeks, with no crossover between the groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cihangir Türemiş
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Cihangir Türemiş, Ministry of Health, Turkey
- Investigators
- Cihangir Türemiş, Dr., Principal investigator, Cesme Alper Cizgenakat State Hospital, İzmir/Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800780
- Sponsor's protocol ID
- SNU6143
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41049371Simental-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.
PubMed 39212129Jabbari 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.
PubMed 35791039Genc 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.
PubMed 39719905
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07800780
- Acronym / sponsor ID
- SNU6143
- Conditions
- Osteoarthritis, Knee
- Keywords
- Collagen, Dietary Supplements, Patient-Reported Outcome Measures, Central Sensitization, Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cihangir TüremişOther government
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale Knee osteoarthritis (OA) is a prevalent joint disorder characterized by progressive cartilage degeneration, chronic pain, and loss of function. While conservative management often includes dietary supplements such as hydrolyzed collagen and bioactive collagen peptides to support joint biology, clinical evaluations of these supplements are typically limited to traditional, unidimensional pain and function scales. Recent literature, however, emphasizes that OA pain is highly complex, involving peripheral nociceptive mechanisms, constant and intermittent pain patterns, and central neurological sensitization. Addressing a significant methodological gap in the literature, this study extends beyond standard scales by incorporating comprehensive Patient-Reported Outcome Measures (PROMs) to capture the holistic pain experience, including central sensitization, in patients with knee OA.
Study Procedures and Blinding This is a single-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial. Following the baseline clinical and radiographic evaluation (Kellgren-Lawrence grading performed by an experienced orthopedic surgeon), eligible participants will be randomly allocated to one of three intervention arms using computer-assisted block randomization.
To ensure strict quadruple blinding (participant, care provider, investigator, and outcomes assessor), allocation concealment will be achieved using independently coded, opaque packaging. The active interventions (two different collagen formulations) and the placebo (maltodextrin-based) will be formulated to be entirely identical in appearance, color, smell, taste, and volume.
Intervention Administration and Monitoring Participants will be instructed to consume their assigned single-use sachet once daily between 13:00 and 15:00 for the entire 8-week intervention period. Patients will be advised to maintain their habitual physical activity levels throughout the study. Rescue analgesics are permitted if necessary for severe pain; however, the use of these medications must be strictly suspended at least 48 hours prior to any clinical evaluation session to avoid masking the outcomes. Adherence to the supplement regimen, rescue medication usage, and any potential adverse events will be continuously monitored via daily follow-up cards filled out by the participants. A minimum adherence rate of 95% is mandatory; participants failing to meet this threshold will be excluded from the final analysis.
Sample Size and Statistical Analysis Plan An a priori power analysis was conducted using G*Power software to determine the required sample size. Based on a Mixed-Design ANOVA model (group × time interaction) aiming for a moderate effect size (Cohen's f = 0.25), an alpha level of 0.05, and 80% statistical power, a minimum of 42 participants was required. To account for potential dropouts, a total of 45 patients (15 per group) will be enrolled.
Statistical analyses will be executed using R software under a Per-Protocol (PP) framework. Data normality will be assessed using the Shapiro-Wilk test. A Mixed-Design ANOVA will be employed to evaluate the main effects and the group-by-time interactions. Significant interactions will be further analyzed with post-hoc pairwise comparisons utilizing the Bonferroni correction. Effect sizes will be reported using Cohen's d for pairwise comparisons and partial eta squared (reported as η²p) for variance analyses, along with corresponding lower and upper bounds (LB/UB). Statistical significance is set at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three parallel intervention arms (Hydrolyzed Collagen, Bioactive Collagen Peptide, or Placebo) in a 1:1:1 ratio. Each participant will receive only their assigned intervention for a continuous period of 8 weeks, with no crossover between the groups.
| Arm | Type | Receives |
|---|---|---|
| Hydrolyzed Collagen | Experimental | Dietary Supplement: 10g Hydrolyzed CollagenParticipants 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 | Experimental | Dietary Supplement: 5g Bioactive Collagen PeptideParticipants 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 comparator | Other: Placebo (Maltodextrin)Participants 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10g Hydrolyzed CollagenA 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. | Dietary supplement | Hydrolyzed Collagen |
| 5g Bioactive Collagen PeptideA 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. | Dietary supplement | Bioactive Collagen Peptide |
| Placebo (Maltodextrin)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. | Other | Placebo |
Primary outcome
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score
Time frame: Baseline (Week 0) and End of Intervention (Week 8)
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.
3 secondary outcomes
Change in Visual Analog Scale (VAS) for Pain
Time frame: Baseline (Week 0) and End of Intervention (Week 8)
Change in Central Sensitization Inventory (CSI) Score
Time frame: Baseline (Week 0) and End of Intervention (Week 8)
Change in Intermittent and Constant Osteoarthritis Pain (ICOAP) Questionnaire Score
Time frame: Baseline (Week 0) and End of Intervention (Week 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 41049371Sun 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.
- Background: PubMed 39212129Simental-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.
- Background: PubMed 35791039Jabbari 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.
- Background: PubMed 39719905Genc 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cihangir Türemiş, Dr. principal investigator
Cesme Alper Cizgenakat State Hospital, İzmir/Türkiye
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10g Hydrolyzed Collagen and 5g Bioactive Collagen Peptide in people with Osteoarthritis, Knee, run by Cihangir Türemiş at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cihangir Türemiş, Dr (+905074182484, cihangirturemis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score (time frame: Baseline (Week 0) and End of Intervention (Week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07800780, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.