Effect of Anti-inflammatory Diet in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04748809
• Other study ID #: 191900
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: November 1, 2025

Study information

• Verified date: May 2024
• Source: University of California, San Diego
• Contact: Monica Guma, MD, 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 rheumatoid arthritis, and the role of microbiome and circulating metabolites.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Diet 1
Dietary intervention
• Diet 2
Dietary intervention

Locations

Country	Name	City	State
United States	UCSD	La Jolla	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	Decrease of more than 5 points in Clinical Disease Activity Index		3 months