Effect of Anti-inflammatory Diet in Rheumatoid Arthritis

Sponsor
University of California, San Diego (Other)
Overall Status
Recruiting
CT.gov ID
NCT04748809
Collaborator
(none)
124
1
2
36
3.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Diet 1
  • Other: Diet 2
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
124 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
An Evaluator-blinded Randomized Controlled Trial Study of the Effect of Anti-inflammatory Diet in Subjects With Rheumatoid Arthritis.
Actual Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm_1

Anti-inflammatory diet 1

Other: Diet 1
Dietary intervention
Other Names:
  • anti-inflammatory diet 1
  • Experimental: Arm_2

    Anti-Inflammatory diet 2

    Other: Diet 2
    Dietary intervention
    Other Names:
  • anti-inflammatory diet 2
  • Outcome Measures

    Primary Outcome Measures

    1. Decrease of more than 5 points in Clinical Disease Activity Index [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCSD La Jolla California United States 92093

    Sponsors and Collaborators

    • University of California, San Diego

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Monica Guma, Associate Professor of Medicine, University of California, San Diego
    ClinicalTrials.gov Identifier:
    NCT04748809
    Other Study ID Numbers:
    • 191900
    First Posted:
    Feb 10, 2021
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 21, 2022