Effect of Anti-inflammatory Diet in Rheumatoid Arthritis

NCT04748809 | Recruiting

• 1 other identifier: 191900
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Decrease of more than 5 points in Clinical Disease Activity Index

  3 months

Study Arms (2)

Arm_1

ACTIVE COMPARATOR

Anti-inflammatory diet 1

Other: Diet 1

Arm_2

EXPERIMENTAL

Anti-Inflammatory diet 2

Other: Diet 2

Interventions

Diet 1 OTHER

Dietary intervention

Also known as: anti-inflammatory diet 1

Arm_1

Diet 2 OTHER

Dietary intervention

Also known as: anti-inflammatory diet 2

Arm_2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD

La Jolla, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Monica Guma, MD, PhD

CONTACT

8588226523; mguma@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 10, 2021
• Study Start: November 1, 2020
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)