Effect of Anti-inflammatory Diet in Rheumatoid Arthritis

Not Applicable

Recruiting

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT04748809
• Lead Sponsor: University of California, San Diego

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 rheumatoid arthritis, and the role of microbiome and circulating metabolites.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-10
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Patients with low or moderate disease activity (defined as Clinical Disease Activity Index ≤ 22) and without changes in disease activity or therapy during the previous 3 months, who are interested in dietary intervention, and are able to provide consent and attend to follow up visits.

Exclusion Criteria

• Pregnancy or lactating. Patients that will become pregnant during the study will be remove from the study.
• Food allergies
• Subjects with significant other comorbidities and /or medication use which in physician's clinical judgment might difficult the interpretation of the results

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Decrease of more than 5 points in Clinical Disease Activity Index	3 months

Trial Locations

Locations (1)

UCSD; 🇺🇸 La Jolla, California, United States