Recruiting

Anti-inflammatory Diet

Sponsor:

UCLA

Code:

NCT06080347

Conditions

Osteoarthritis, Knee

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Anti-inflammatory Diet

Healthy Diet

Study Details

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.

Conditions

Osteoarthritis, Knee

Study ID

NCT06080347

Start date

Oct 1, 2023

Status verified date

Oct, 2024

Completion date

Jan 1, 2026

Anticipated

Primary completion date

Jan 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Arm 1

Anti-inflammatory Diet

experimental: Arm 2

Healthy Diet

Interventions

Anti-inflammatory Diet

Dietary intervention

Healthy Diet

Dietary intervention

Primary outcome measure

  • Change in Knee Osteoarthritis Pain [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Monica Guma, M.D., PhD

8588226523mguma@health.ucsd.edu

Locations

University of California

Recruiting

San Diego, California, United States, 92122

Contacts

Monica Guma, M.D, PHD

mguma@health.ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Nov 4, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2024-11-04.