NCT06080347RecruitingNot Applicable

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

University of California, San Diego2 sites in 1 country72 target enrollmentStarted: October 1, 2023Last updated: November 4, 2024

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Recruiting
Sponsor: University of California, San Diego
Enrollment: 72
Locations: 2
Primary Endpoint: Change in Knee Osteoarthritis Pain

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Supportive Care
Masking: Double (Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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

Outcomes

Primary Outcomes

Change in Knee Osteoarthritis Pain

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor

University of California, San Diego

Sponsor Class

Other

Responsible Party

Principal Investigator

Monica Guma

Associate Professor

University of California, San Diego

Study Sites (2)

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