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

NCT ID: NCT04999683

Last Updated: 2022-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2022-09-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ITIS diet

anti-inflammatory (ITIS) diet for 14 days

Group Type EXPERIMENTAL

ITIS diet

Intervention Type DIETARY_SUPPLEMENT

anti-inflammatory diet for 14 days

Interventions

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ITIS diet

anti-inflammatory diet for 14 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* food allergies
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Monica Guma

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UCSD

La Jolla, California, United States

Site Status

Countries

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United States

References

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Sala-Climent M, Lal E, Cedola F, Alharthi M, Fernandez-Bustamante M, Agustin-Perez M, Singh A, Choi SI, Rivera T, Nguyen K, Lee S, Golshan S, Holt T, Quehenberger O, Coras R, Guma M. Oxylipin serum profile changes in response to an open-label anti-inflammatory dietary intervention. Clin Nutr ESPEN. 2025 Aug;68:389-402. doi: 10.1016/j.clnesp.2025.05.027. Epub 2025 May 23.

Reference Type DERIVED
PMID: 40414498 (View on PubMed)

Other Identifiers

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161474

Identifier Type: -

Identifier Source: org_study_id

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