Ultra Processed Foods Consumption and Impact in Rheumatic Diseases.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospices Civils de Lyon
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years
chronic rheumatic disease (Rheumatoid arthritis, spondyloarthritis, osteoarthritis)
ability to perform questionnaires
Disqualifiers
Judicial protection measure
Refusal to participate in the study
Suffering from 2 rheumatic disease simultaneously
Trial population
Patients with chronic rheumatological diseases (spondylitis, rheumatoid arthritis, osteoarthritis) and control population (also followed for any other pathology in the department).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Dietary Questionnaire
Other interventionSelf administered dietary questionnaire at baseline, 6 and 12 months.
Evaluation of disease activity (DAS-28, ASDAS, EVA, number of swollen joints, number of painful joint, nocturnal pain, morning stiffness)
Other interventionSelf administered questionnaire of disease activity at baseline, 6 and 12 months.
Treatment groups
240 Participants
are divided into 4 treatment groupsGroup A: Rheumatoid Arthritis2 interventions
Group B: Spondyloarthritis2 interventions
Group C: Osteoarthritis2 interventions
Group D: Controls2 interventions
Trial outcomes
Primary outcomes
1
Describe the consumption of ultra-processed foods in patients with chronic inflammatory rheumatism
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.
Time frame
At baselineSponsors and contacts
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Source ClinicalTrials.gov