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

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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

Tracking Information
First Submitted Date  ICMJE August 2, 2021
First Posted Date  ICMJE August 11, 2021
Last Update Posted Date November 1, 2022
Actual Study Start Date  ICMJE September 1, 2018
Actual Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2021)		 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 9, 2021)		 Decrease of 50% of baseline pain measured by visual analogue scale (0-10) [ Time Frame: 2 weeks ]
decrease of 50% of baseline pain
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Anti-inflammatory (ITIS) Diet in Rheumatoid Arthritis
Official Title  ICMJE Effect of Anti-inflammatory (ITIS) Diet in Rheumatoid Arthritis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Rheumatoid Arthritis
  • Osteoarthritis
Intervention  ICMJE Dietary Supplement: ITIS diet
anti-inflammatory diet for 14 days
Study Arms  ICMJE Experimental: ITIS diet
anti-inflammatory (ITIS) diet for 14 days
Intervention: Dietary Supplement: ITIS diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 9, 2021)		 26
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 1, 2022
Actual Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • food allergies
  • pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04999683
Other Study ID Numbers  ICMJE 161474
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Monica Guma, University of California, San Diego
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, San Diego
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, San Diego
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP