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NCT04999683 Clinical Trial

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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04999683
Other study ID # 161474
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date September 1, 2022

Study information
Verified date May 2022
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date September 1, 2022
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients diagnosed of rheumatoid arthritis - without changes in treatment in the last 3 months Exclusion Criteria: - food allergies - pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• ITIS diet
anti-inflammatory diet for 14 days

Locations
Country Name City State
United States UCSD La Jolla California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of baseline pain measured by visual analogue scale (0-10) after two weeks of ITIS diet Change of baseline pain measured by visual analogue scale after two weeks of ITIS diet, being 0 no pain, and 10 worse pain 2 weeks
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