Ultra Processed Foods Consumption and Impact in Rheumatic Diseases.

NCT06776965 | Recruiting

• 2 other identifiers: 69HCL24_09472024-A02327-40
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis; Spondyloarthritis; Osteoarthritis

Keywords

Ultra-processed food; osteoarthritis; rheumatoid arthritis; spondyloarthritis

Outcome Measures

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.

  At baseline

Study Arms (4)

Rheumatoid Arthritis

Patients in the first group will correspond to those with rheumatoid arthritis according to ACR criteria of RA

Other: Dietary Questionnaire; Other: Evaluation of disease activity (DAS-28, ASDAS, EVA, number of swollen joints, number of painful joint, nocturnal pain, morning stiffness)

Spondyloarthritis

Patients in the second group will correspond to those with spondyloarthritis according ASDAS criteria

Other: Dietary Questionnaire; Other: Evaluation of disease activity (DAS-28, ASDAS, EVA, number of swollen joints, number of painful joint, nocturnal pain, morning stiffness)

Osteoarthritis

Patients in the third group will correspond to those with spondyloarthritis according ACR criteria

Other: Dietary Questionnaire; Other: Evaluation of disease activity (DAS-28, ASDAS, EVA, number of swollen joints, number of painful joint, nocturnal pain, morning stiffness)

Controls

Patients without rheumatic disease

Other: Dietary Questionnaire; Other: Evaluation of disease activity (DAS-28, ASDAS, EVA, number of swollen joints, number of painful joint, nocturnal pain, morning stiffness)

Interventions

Dietary Questionnaire OTHER

Self administered dietary questionnaire at baseline, 6 and 12 months.

Controls; Osteoarthritis; Rheumatoid Arthritis; Spondyloarthritis

Evaluation of disease activity (DAS-28, ASDAS, EVA, number of swollen joints, number of painful joint, nocturnal pain, morning stiffness) OTHER

Self administered questionnaire of disease activity at baseline, 6 and 12 months.

Controls; Osteoarthritis; Rheumatoid Arthritis; Spondyloarthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Edouard Herriot Hospital

Lyon, 69003, France

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylarthritis; Osteoarthritis

Interventions

Extravehicular Activity

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylitis; Spinal Diseases; Bone Diseases

Intervention Hierarchy (Ancestors)

Space Flight; Aviation; Transportation; Technology, Industry, and Agriculture

Study Officials

• Maxime AUROUX, MD

  Hôpital Edouard Herriot

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maxime AUROUX, MD

CONTACT

+33472117479; Maxime.auroux@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: March 31, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

FR (1)