Effect of Anti-inflammatory Diet in Osteoarthritis

University of California San Diego

Status: Enrolling

Conditions: Osteoarthritis, Knee

Treatments: Other: Anti-inflammatory Diet; Other: Healthy Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06080347

807845

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

Arm_1

Active Comparator group

Description:

Anti-inflammatory Diet

Treatment:

Other: Anti-inflammatory Diet

Arm_2

Experimental group

Description:

Healthy Diet

Treatment:

Other: Healthy Diet