- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04748809
Effect of Anti-inflammatory Diet in Rheumatoid Arthritis
May 7, 2024 updated by: Monica Guma, University of California, San Diego
An Evaluator-blinded Randomized Controlled Trial Study of the Effect of Anti-inflammatory Diet in Subjects With Rheumatoid Arthritis.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
124
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Monica Guma, MD, PhD
- Phone Number: 8588226523
- Email: mguma@health.ucsd.edu
Study Locations
-
-
California
-
La Jolla, California, United States, 92093
- Recruiting
- UCSD
-
Contact:
- Monica Guma, MD
- Email: mguma@health.ucsd.edu
-
Principal Investigator:
- Monica Guma, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm_1
Anti-inflammatory diet 1
|
Dietary intervention
Other Names:
|
Experimental: Arm_2
Anti-Inflammatory diet 2
|
Dietary intervention
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Decrease of more than 5 points in Clinical Disease Activity Index
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2020
Primary Completion (Estimated)
November 1, 2025
Study Completion (Estimated)
November 1, 2025
Study Registration Dates
First Submitted
January 26, 2021
First Submitted That Met QC Criteria
February 5, 2021
First Posted (Actual)
February 10, 2021
Study Record Updates
Last Update Posted (Actual)
May 8, 2024
Last Update Submitted That Met QC Criteria
May 7, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 191900
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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AmgenTerminated
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