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Effect of Anti-inflammatory Diet in Rheumatoid Arthritis

NCT ID: NCT04748809

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2025-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Arm_1

Anti-inflammatory diet 1

Group Type ACTIVE_COMPARATOR

Diet 1

Intervention Type OTHER

Dietary intervention

Arm_2

Anti-Inflammatory diet 2

Group Type EXPERIMENTAL

Diet 2

Intervention Type OTHER

Dietary intervention

Interventions

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Diet 1

Dietary intervention

Intervention Type OTHER

Diet 2

Dietary intervention

Intervention Type OTHER

Other Intervention Names

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anti-inflammatory diet 1 anti-inflammatory diet 2

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Monica Guma

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UCSD

La Jolla, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Monica Guma, MD, PhD

Role: CONTACT

Phone: 8588226523

Email: [email protected]

Facility Contacts

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Monica Guma, MD

Role: primary

Other Identifiers

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191900

Identifier Type: -

Identifier Source: org_study_id