Effects of Different Collagen Formulations on Knee Osteoarthritis

Sponsor
Cihangir Türemiş
Study ID
NCT07800780
Status
Not Yet Recruiting

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Conditions

  • Osteoarthritis, Knee

Eligibility Criteria

Sex
ALL
Age
35 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 10g Hydrolyzed Collagen — DIETARY_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 Peptide — DIETARY_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 Details

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.

Key Dates

First listed
Sep 2, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Hydrolyzed Collagen
    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.
  • Experimental: Bioactive Collagen Peptide
    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.
  • Placebo Comparator: Placebo
    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.

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) ]

Central Contacts

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