Ultra Processed Foods Consumption and Impact in Rheumatic Diseases. (NUTRIRIC)

April 10, 2025 updated by: Hospices Civils de Lyon

Impact of Ultra-processed Foods in a Population of Patients With Chronic Rheumatic Diseases (Rheumatoid Arthritis, Spondyloarthritis, Osteoarthritis).

Ultra-processed foods (UPF) represent one of the mainstays of today's diet. They are defined by the NOVA classification system. It was demonstrated that UPF consumption was associated with activity of inflammatory bowel diseases with underlying mechanisms not fully identified yet. It is suspected that UPF constituents could modify the gut microbiota, increase intestinal barrier permeability and directly engage immune surveillance systems, effects that could individually or synergistically increase the risk of immunomediated diseases. As some pathophysiological mechanisms are shared among IBD and rheumatic diseases, we have wondered if UPF consumption could be associated with increased risk of rheumatic disease and/or with their activity.

Our primary aim will be to study the pattern of UPF consumption in patients with rheumatic diseases. Our secondary objectives will be to study the activity of diseases according to UPF consumption.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

240

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

Study Locations

  • France
      • Lyon, France, 69003
        • Recruiting
        • Edouard Herriot Hospital
        • Contact:
        • Principal Investigator:
          • Maxime AUROUX, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic rheumatological diseases (spondylitis, rheumatoid arthritis, osteoarthritis) and control population (also followed for any other pathology in the department).

Description

Inclusion Criteria:

  • Age > 18 years
  • chronic rheumatic disease (Rheumatoid arthritis, spondyloarthritis, osteoarthritis)
  • ability to perform questionnaires

Exclusion Criteria:

  • Judicial protection measure
  • Refusal to participate in the study
  • Suffering from 2 rheumatic disease simultaneously

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rheumatoid Arthritis
Patients in the first group will correspond to those with rheumatoid arthritis according to ACR criteria of RA
Other: Dietary Questionnaire
Self administered dietary questionnaire at baseline, 6 and 12 months.
Other: Evaluation of disease activity (DAS-28, ASDAS, EVA, number of swollen joints, number of painful joint, nocturnal pain, morning stiffness)
Self administered questionnaire of disease activity at baseline, 6 and 12 months.
Spondyloarthritis
Patients in the second group will correspond to those with spondyloarthritis according ASDAS criteria
Other: Dietary Questionnaire
Self administered dietary questionnaire at baseline, 6 and 12 months.
Other: Evaluation of disease activity (DAS-28, ASDAS, EVA, number of swollen joints, number of painful joint, nocturnal pain, morning stiffness)
Self administered questionnaire of disease activity at baseline, 6 and 12 months.
Osteoarthritis
Patients in the third group will correspond to those with spondyloarthritis according ACR criteria
Other: Dietary Questionnaire
Self administered dietary questionnaire at baseline, 6 and 12 months.
Other: Evaluation of disease activity (DAS-28, ASDAS, EVA, number of swollen joints, number of painful joint, nocturnal pain, morning stiffness)
Self administered questionnaire of disease activity at baseline, 6 and 12 months.
Controls
Patients without rheumatic disease
Other: Dietary Questionnaire
Self administered dietary questionnaire at baseline, 6 and 12 months.
Other: Evaluation of disease activity (DAS-28, ASDAS, EVA, number of swollen joints, number of painful joint, nocturnal pain, morning stiffness)
Self administered questionnaire of disease activity at baseline, 6 and 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the consumption of ultra-processed foods in patients with chronic inflammatory rheumatism
Time Frame: At baseline
Describes the consumption of ultra-processed foods in patients with chronic inflammatory rheumatism using a self-assessment questionnaire (Score UPF Nova Screener) completed at baseline, 6 and 12 months.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Maxime AUROUX, MD, Edouard Herriot Hospital

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)

March 31, 2025

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 10, 2025

First Posted (Actual)

January 15, 2025

Study Record Updates

Last Update Posted (Actual)

April 11, 2025

Last Update Submitted That Met QC Criteria

April 10, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL24_0947
  • 2024-A02327-40 (Other Identifier: ID-RCB)

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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