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Effect of Anti-inflammatory Diet in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet 1
Diet 2
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with low or moderate disease activity (defined as Clinical Disease Activity Index ≤ 22) and without changes in disease activity or therapy during the previous 3 months, who are interested in dietary intervention, and are able to provide consent and attend to follow up visits.

Exclusion Criteria:

  • Pregnancy or lactating. Patients that will become pregnant during the study will be remove from the study.
  • Food allergies
  • Subjects with significant other comorbidities and /or medication use which in physician's clinical judgment might difficult the interpretation of the results

Sites / Locations

  • UCSDRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm_1

Arm_2

Arm Description

Anti-inflammatory diet 1

Anti-Inflammatory diet 2

Outcomes

Primary Outcome Measures

Decrease of more than 5 points in Clinical Disease Activity Index

Secondary Outcome Measures

Full Information

First Posted
January 26, 2021
Last Updated
August 3, 2023
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT04748809
Brief Title
Effect of Anti-inflammatory Diet in Rheumatoid Arthritis
Official Title
An Evaluator-blinded Randomized Controlled Trial Study of the Effect of Anti-inflammatory Diet in Subjects With Rheumatoid Arthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

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
In a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet. The investigators also observed change in microbiome and circulating metabolites. The current study will determine whether or not the addition of anti-inflammatory diet improves the clinical outcomes in participants with rheumatoid arthritis, and the role of microbiome and circulating metabolites.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm_1
Arm Type
Active Comparator
Arm Description
Anti-inflammatory diet 1
Arm Title
Arm_2
Arm Type
Experimental
Arm Description
Anti-Inflammatory diet 2
Intervention Type
Other
Intervention Name(s)
Diet 1
Other Intervention Name(s)
anti-inflammatory diet 1
Intervention Description
Dietary intervention
Intervention Type
Other
Intervention Name(s)
Diet 2
Other Intervention Name(s)
anti-inflammatory diet 2
Intervention Description
Dietary intervention
Primary Outcome Measure Information:
Title
Decrease of more than 5 points in Clinical Disease Activity Index
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with low or moderate disease activity (defined as Clinical Disease Activity Index ≤ 22) and without changes in disease activity or therapy during the previous 3 months, who are interested in dietary intervention, and are able to provide consent and attend to follow up visits. Exclusion Criteria: Pregnancy or lactating. Patients that will become pregnant during the study will be remove from the study. Food allergies Subjects with significant other comorbidities and /or medication use which in physician's clinical judgment might difficult the interpretation of the results
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monica Guma, MD, PhD
Phone
8588226523
Email
mguma@health.ucsd.edu
Facility Information:
Facility Name
UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica Guma, MD
Email
mguma@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Monica Guma, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Anti-inflammatory Diet in Rheumatoid Arthritis

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