Effect of Anti-inflammatory Diet in Osteoarthritis

Not Applicable

Recruiting

• Conditions: Osteoarthritis, Knee
• Interventions: Other: Anti-inflammatory Diet; Other: Healthy Diet

• Registration Number: NCT06080347
• Lead Sponsor: University of California, San Diego

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2023-10-06
• Study First Submitted QC: 2023-10-06
• Study First Posted: 2023-10-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm_1	Anti-inflammatory Diet	Anti-inflammatory Diet
Arm_2	Healthy Diet	Healthy Diet

Primary Outcome Measures

Name	Time	Method
Change in Knee Osteoarthritis Pain	3 months	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.

Trial Locations

Locations (1)

University of California; 🇺🇸 San Diego, California, United States