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NCT06080347 | RECRUITING | Osteoarthritis, Knee

Effect of Anti-inflammatory Diet in Osteoarthritis
Sponsor:

University of California, San Diego

Information provided by (Responsible Party):

Monica Guma

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.

Condition or disease

Osteoarthritis, Knee

Intervention/treatment

Anti-inflammatory Diet

Healthy Diet

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 72 participants
Masking : DOUBLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : An Evaluator-blinded Randomized Controlled Trial Study of the Effect of Anti-inflammatory Diet in Subjects With Osteoarthritis
Actual Study Start Date : 2023-10-01
Estimated Primary Completion Date : 2025-01-01
Estimated Study Completion Date : 2025-01-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
  • * 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
Effect of Anti-inflammatory Diet in Osteoarthritis

Location Details

NCT06080347

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

University of California

San Diego, California, United States, 92122