Back to resultsEffect of Anti-inflammatory (ITIS) Diet in Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis, Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ITIS diet
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- patients diagnosed of rheumatoid arthritis
- without changes in treatment in the last 3 months
Exclusion Criteria:
- food allergies
- pregnancy
Sites / Locations
- UCSD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ITIS diet
Arm Description
anti-inflammatory (ITIS) diet for 14 days
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04999683
First Posted
August 2, 2021
Last Updated
October 31, 2022
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT04999683
Brief Title
Effect of Anti-inflammatory (ITIS) Diet in Rheumatoid Arthritis
Official Title
Effect of Anti-inflammatory (ITIS) Diet in Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ITIS diet
Arm Type
Experimental
Arm Description
anti-inflammatory (ITIS) diet for 14 days
Intervention Type
Dietary Supplement
Intervention Name(s)
ITIS diet
Intervention Description
anti-inflammatory diet for 14 days
Primary Outcome Measure Information:
Title
Change of baseline pain measured by visual analogue scale (0-10) after two weeks of ITIS diet
Description
Change of baseline pain measured by visual analogue scale after two weeks of ITIS diet, being 0 no pain, and 10 worse pain
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients diagnosed of rheumatoid arthritis
without changes in treatment in the last 3 months
Exclusion Criteria:
food allergies
pregnancy
Facility Information:
Facility Name
UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Anti-inflammatory (ITIS) Diet in Rheumatoid Arthritis
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