Ultra Processed Foods Consumption and Impact in Rheumatic Diseases.

NCT ID: NCT06776965

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-31

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis Spondyloarthritis Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rheumatoid Arthritis

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

Dietary Questionnaire

Intervention Type OTHER

Self 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)

Intervention Type OTHER

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

Dietary Questionnaire

Intervention Type OTHER

Self 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)

Intervention Type OTHER

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

Dietary Questionnaire

Intervention Type OTHER

Self 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)

Intervention Type OTHER

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

Controls

Patients without rheumatic disease

Dietary Questionnaire

Intervention Type OTHER

Self 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)

Intervention Type OTHER

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

Interventions

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Dietary Questionnaire

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maxime AUROUX, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Edouard Herriot

Locations

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Edouard Herriot Hospital

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Maxime AUROUX, MD

Role: CONTACT

+33472117479

Facility Contacts

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Maxime AUROUX, MD

Role: primary

Other Identifiers

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2024-A02327-40

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL24_0947

Identifier Type: -

Identifier Source: org_study_id

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