Effect of Anti-inflammatory Diet in Rheumatoid Arthritis

University of California San Diego

Status: Enrolling

Conditions: Rheumatoid Arthritis

Treatments: Other: Diet 2; Other: Diet 1

Study type: Interventional

Funder types: Other

Identifiers

NCT04748809

191900

Details and patient eligibility

About

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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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124 participants in 2 patient groups

Arm_1

Active Comparator group

Description:

Anti-inflammatory diet 1

Treatment:

Other: Diet 1

Arm_2

Experimental group

Description:

Anti-Inflammatory diet 2

Treatment:

Other: Diet 2