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

Sponsor

University of California, San Diego (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04999683

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Osteoarthritis	Dietary Supplement: ITIS diet	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2018

Actual Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ITIS diet anti-inflammatory (ITIS) diet for 14 days	Dietary Supplement: ITIS diet anti-inflammatory diet for 14 days

Arm

Intervention/Treatment

Experimental: ITIS diet

anti-inflammatory (ITIS) diet for 14 days

Dietary Supplement: ITIS diet

anti-inflammatory diet for 14 days

Outcome Measures

Primary Outcome Measures

Change of baseline pain measured by visual analogue scale (0-10) after two weeks of ITIS diet [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

food allergies
pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCSD	La Jolla	California	United States	92093

Sponsors and Collaborators

University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Monica Guma, Associate Professor of Medicine, University of California, San Diego

ClinicalTrials.gov Identifier:

NCT04999683

Other Study ID Numbers:

161474

First Posted:

Aug 11, 2021

Last Update Posted:

May 18, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Study Results

No Results Posted as of May 18, 2022