Effect of Anti-inflammatory Diet in Osteoarthritis

Study Overview
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Brief Summary
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In a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet. The investigators also observed change in microbiome and circulating metabolites. The current study will determine whether or not the addition of anti-inflammatory diet improves the clinical outcomes in participants with Osteoarthritis, and the role of microbiome and circulating metabolites.

Official Title
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An Evaluator-blinded Randomized Controlled Trial Study of the Effect of Anti-inflammatory Diet in Subjects With Osteoarthritis

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Other: Anti-inflammatory Diet
* Other: Healthy Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral radiographic symptomatic KOA No changes in therapy during the previous 3 months Interested in dietary intervention and able to provide consent and attend follow-up visits Exclusion Criteria: Previous knee surgery Severe radiographic disease (KL grade 4) Rheumatoid Arthritis Any Abnormal blood values in the comprehensive metabolic panel test at screen (Abnormality will be defined based on standard reference ranges) Use of corticosteroids and/or intra-articular injections during the preceding 3 months Use of fish oils and glucosamine Participation in a weight loss program in the preceding 6 months Recent changes in physical activity levels Regular smoking Patients with food allergies Patient with other medical conditions that will impair the ability to participate in a nutritional study Plan to change systemic therapy Patients unwilling to change dietary habits

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm_1<br>Anti-inflammatory Diet | Other: Anti-inflammatory Diet<br>* Dietary intervention<br>|
| Experimental: Arm_2<br>Healthy Diet | Other: Healthy Diet<br>* Dietary intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knee Osteoarthritis Pain | The Western Ontario and McMaster Universities Osteoarthritis Index, known as the WOMAC score, is a validated questionnaire used for evaluating pain, stiffness, and physical function in individuals with knee or hip osteoarthritis. A minimum score of 0 indicates no symptoms and a maximum score of 100, represents the most severe symptoms. Higher WOMAC scores correspond to worse outcomes, indicating more significant pain, stiffness, and functional limitations associated with osteoarthritis. The primary outcome for the purpose of this study will be the proportion of patients experiencing a change of at least 30% in WOMAC-pain score after 3 months of intervention compared to the control group. | 3 months |