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Clinical Trials/NCT04999683
NCT04999683
Completed
Not Applicable

Effect of Anti-inflammatory (ITIS) Diet in Rheumatoid Arthritis

University of California, San Diego1 site in 1 country26 target enrollmentSeptember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rheumatoid Arthritis
Sponsor
University of California, San Diego
Enrollment
26
Locations
1
Primary Endpoint
Change of baseline pain measured by visual analogue scale (0-10) after two weeks of ITIS diet
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

to study the effect of anti-inflammatory diet on clinical and biological outcomes in rheumatoid arthritis

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
September 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Monica Guma

Associate Professor of Medicine

University of California, San Diego

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • food allergies
  • pregnancy

Outcomes

Primary Outcomes

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

Study Sites (1)

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