Recruiting

Anti-inflammatory Diet

Sponsor:

UCLA

Code:

NCT04748809

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diet 1

Diet 2

Study Details

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

Study ID

NCT04748809

Start date

Nov 1, 2020

Status verified date

Jan, 2026

Completion date

Mar 1, 2026

Anticipated

Primary completion date

Feb 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

124 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Arm 1

Anti-inflammatory diet 1

experimental: Arm 2

Anti-Inflammatory diet 2

Interventions

Diet 1

Dietary intervention

Diet 2

Dietary intervention

Primary outcome measure

  • Decrease of more than 5 points in Clinical Disease Activity Index [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Monica Guma, MD, PhD

8588226523mguma@health.ucsd.edu

Locations

UCSD

Recruiting

La Jolla, California, United States, 92093

Contacts

Monica Guma, MD

mguma@health.ucsd.edu

Principal Investigator:

Monica Guma, MD, PhD

More Information

Sponsor

University of California, San Diego

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-01-09.