Effect of Anti-inflammatory Diet in Osteoarthritis

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06080347

Enrollment

Registered

2023-10-12

Start date

2023-10-01

Completion date

2026-01-01

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

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.

Interventions

OTHERAnti-inflammatory Diet

Dietary intervention

OTHERHealthy Diet

Dietary intervention

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Knee Osteoarthritis Pain	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.

Countries

United States

Contacts

Primary ContactMonica Guma, M.D., PhD

mguma@health.ucsd.edu8588226523

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026