Effect of Anti-inflammatory Diet in Osteoarthritis

University of California, San Diego72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

Anti-inflammatory DietOTHER

Dietary intervention

Healthy DietOTHER

Dietary intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of California

San Diego, California, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Central Contacts

Monica Guma, M.D., PhD

CONTACT

8588226523 mguma@health.ucsd.edu

Data from ClinicalTrials.gov

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