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Effect of Anti-inflammatory (ITIS) 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04999683
Recruitment Status : Completed
First Posted : August 11, 2021
Last Update Posted : November 1, 2022
Sponsor:
Information provided by (Responsible Party):
Monica Guma, University of California, San Diego

Study Description
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Brief Summary:
to study the effect of anti-inflammatory diet on clinical and biological outcomes in rheumatoid arthritis

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Osteoarthritis Dietary Supplement: ITIS diet Not Applicable

Detailed Description:
The investigators would like to evaluate how inflammation occurs in the joints of subjects with arthritis, and identify molecules and bacteria that can predict whether a rheumatic subject will flare. Blood, urine and stool will be evaluated in the laboratory and compared to their own samples after changes in diet. This is an exploratory study, which is meant to gather preliminary data about the quick effects of changes in diet and treatment on molecules in blood/urine and bacteria in stools. These studies can provide clues to the cause of disease and might ultimately lead to new therapies.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Anti-inflammatory (ITIS) Diet in Rheumatoid Arthritis
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : September 1, 2021
Actual Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ITIS diet
anti-inflammatory (ITIS) diet for 14 days
 Dietary Supplement: ITIS diet
anti-inflammatory diet for 14 days


Outcome Measures
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Primary Outcome Measures :
  1. Change of baseline pain measured by visual analogue scale (0-10) after two weeks of ITIS diet [ Time Frame: 2 weeks ]
    Change of baseline pain measured by visual analogue scale after two weeks of ITIS diet, being 0 no pain, and 10 worse pain


Eligibility Criteria
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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 diagnosed of rheumatoid arthritis
  • without changes in treatment in the last 3 months

Exclusion Criteria:

  • food allergies
  • pregnancy
Contacts and Locations
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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): NCT04999683


Locations
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United States, California
UCSD
La Jolla, California, United States, 92093
Sponsors and Collaborators
University of California, San Diego
More Information
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Responsible Party: Monica Guma, Associate Professor of Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04999683    
Other Study ID Numbers: 161474
First Posted: August 11, 2021    Key Record Dates
Last Update Posted: November 1, 2022
Last Verified: May 2022
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