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Clinical Trials/NCT06080347
NCT06080347
Recruiting
Not Applicable

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

University of California, San Diego1 site in 1 country72 target enrollmentOctober 1, 2023
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ConditionsOsteoarthritis, Knee

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
University of California, San Diego
Enrollment
72
Locations
1
Primary Endpoint
Change in Knee Osteoarthritis Pain
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
January 1, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Monica Guma

Associate Professor

University of California, San Diego

Eligibility Criteria

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

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.

Study Sites (1)

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