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OpenTrials
Completed

NCT Number: NCT04999683

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCSD

La Jolla, California, 92093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • food allergies
  • pregnancy

Treatment and study plan

ITIS diet

Dietary Supplement

anti-inflammatory diet for 14 days

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Aug 11, 2021
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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