Effect of Anti-inflammatory Diet in Osteoarthritis

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06080347
• Other study ID #: 807845
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: October 2023
• Source: University of California, San Diego
• Contact: Monica Guma, M.D., PhD
• Phone: 8588226523
• Email: mguma[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Anti-inflammatory Diet
Dietary intervention
• Healthy Diet
Dietary intervention

Locations

Country	Name	City	State
United States	University of California	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Knee Osteoarthritis Pain	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.	3 months