Effects of Different Collagen Formulations on Knee Osteoarthritis

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.

Conditions

• Osteoarthritis, Knee

Interventions

DIETARY_SUPPLEMENT

10g Hydrolyzed Collagen

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.

DIETARY_SUPPLEMENT

5g Bioactive Collagen Peptide

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.

OTHER

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.

Sponsors & Collaborators

• Cihangir Türemiş

  lead OTHER_GOV

Principal Investigators

• Cihangir Türemiş, Dr. · Cesme Alper Cizgenakat State Hospital, İzmir/Türkiye

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-01

Primary Completion

2027-05-01

Completion

2027-05-01

Countries

• Turkey (Türkiye)

Study Locations