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Recruiting NCT06776965

Ultra Processed Foods Consumption and Impact in Rheumatic Diseases.

Observational Rheumatoid Arthritis Spondyloarthritis Osteoarthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dietary Questionnaire, Evaluation of disease activity (DAS-28, ASDAS, EVA, number of swollen joints, number of painful joint, nocturnal pain, morning stiffness).
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis, Spondyloarthritis, Osteoarthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Describe the consumption of ultra-processed foods in patients with chronic inflammatory rheumatism [Time frame: At baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Edouard Herriot Hospital — Lyon

Identifiers

NCT: NCT06776965 · 69HCL24_0947 · 2024-A02327-40

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗