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Effect of Anti-inflammatory Diet in Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04748809
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Monica Guma, University of California, San Diego

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
Rheumatoid Arthritis Other: Diet 1 Other: Diet 2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 1, 2020
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm_1
Anti-inflammatory diet 1
Other: Diet 1
Dietary intervention
Other Name: anti-inflammatory diet 1

Experimental: Arm_2
Anti-Inflammatory diet 2
Other: Diet 2
Dietary intervention
Other Name: anti-inflammatory diet 2




Primary Outcome Measures :
  1. Decrease of more than 5 points in Clinical Disease Activity Index [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04748809


Contacts
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Contact: Monica Guma, MD, PhD 8588226523 mguma@health.ucsd.edu

Locations
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United States, California
UCSD Recruiting
La Jolla, California, United States, 92093
Contact: Roxana Coras, MD    858-822-6523    rcoras@health.ucsd.edu   
Principal Investigator: Monica Guma, MD, PhD         
Sponsors and Collaborators
University of California, San Diego
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Responsible Party: Monica Guma, Associate Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04748809    
Other Study ID Numbers: 191900
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents