NCT04748809
Recruiting
N/A
An Evaluator-blinded Randomized Controlled Trial Study of the Effect of Anti-inflammatory Diet in Subjects With Rheumatoid Arthritis.
ConditionsRheumatoid Arthritis
Overview
- Phase
- N/A
- Intervention
- Diet 1
- Conditions
- Rheumatoid Arthritis
- Sponsor
- University of California, San Diego
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- Decrease of more than 5 points in Clinical Disease Activity Index
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
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.
Investigators
Monica Guma
Associate Professor of Medicine
University of California, San Diego
Eligibility Criteria
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
Arms & Interventions
Arm_1
Anti-inflammatory diet 1
Intervention: Diet 1
Arm_2
Anti-Inflammatory diet 2
Intervention: Diet 2
Outcomes
Primary Outcomes
Decrease of more than 5 points in Clinical Disease Activity Index
Time Frame: 3 months
Study Sites (1)
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