Rheumatoid ArthritisNUTRIRICNCT06776965
Ultra Processed Foods Consumption and Impact in Rheumatic Diseases.
An observational study of Rheumatoid Arthritis and Spondyloarthritis, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Spondyloarthritis, Osteoarthritis
- What is being tested?
- Dietary Questionnaire and Evaluation of disease activity (DAS-28, ASDAS, EVA, number of swollen joints, number of painful joint, nocturnal pain, morning stiffness)
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2025to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic rheumatological diseases (spondylitis, rheumatoid arthritis, osteoarthritis) and control population (also followed for any other pathology in the department).
Who may be able to join
- Age > 18 years
- chronic rheumatic disease (Rheumatoid arthritis, spondyloarthritis, osteoarthritis)
- ability to perform questionnaires
Who cannot join
- Judicial protection measure
- Refusal to participate in the study
- Suffering from 2 rheumatic disease simultaneously
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Edouard Herriot Hospital
Lyon, 69003
Maxime AUROUX, MD, Maxime.auroux@chu-lyon.fr
Maxime AUROUX, MD
About this study
Official title: 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.
- Conditions
- Rheumatoid Arthritis, Spondyloarthritis, Osteoarthritis
- Being tested
- Dietary Questionnaire, Evaluation of disease activity (DAS-28, ASDAS, EVA, number of swollen joints, number of painful joint, nocturnal pain, morning stiffness)
- Keywords
- Ultra-processed food, osteoarthritis, rheumatoid arthritis, spondyloarthritis
- Medical subject headings
- Arthritis, Rheumatoid, Spondylarthritis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary QuestionnaireOther
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)Other
Self administered questionnaire of disease activity at baseline, 6 and 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis | Patients in the first group will correspond to those with rheumatoid arthritis according to ACR criteria of RA Receives: 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 Receives: 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 Receives: 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 Receives: Other: Dietary Questionnaire; Other: Evaluation of disease activity (DAS-28, ASDAS, EVA, number of swollen joints, number of painful joint, nocturnal pain, morning stiffness) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start31 Mar 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxime AUROUX, MD, Principal investigator, Hôpital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776965
- Sponsor's protocol ID
- 69HCL24_0947
- Other IDs
- 2024-A02327-40
- Acronym
- NUTRIRIC
- Status last verified
- Apr 2025
- First submitted
- 10 Jan 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ultra-processed Foods in a Population of Patients With Chronic Rheumatic Diseases (Rheumatoid Arthritis, Spondyloarthritis, Osteoarthritis).
- ClinicalTrials.gov ID
- NCT06776965
- Acronym / sponsor ID
- NUTRIRIC / 69HCL24_0947
- Conditions
- Rheumatoid Arthritis, Spondyloarthritis, Osteoarthritis
- Keywords
- Ultra-processed food, osteoarthritis, rheumatoid arthritis, spondyloarthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis | – | Other: Dietary Questionnaire, Other: Evaluation of disease activity (DAS-28, ASDAS, EVA, number of swollen joints, number of painful joint, nocturnal pain, morning stiffness)Patients in the first group will correspond to those with rheumatoid arthritis according to ACR criteria of RA |
| Spondyloarthritis | – | Other: Dietary Questionnaire, Other: Evaluation of disease activity (DAS-28, ASDAS, EVA, number of swollen joints, number of painful joint, nocturnal pain, morning stiffness)Patients in the second group will correspond to those with spondyloarthritis according ASDAS criteria |
| Osteoarthritis | – | Other: Dietary Questionnaire, Other: Evaluation of disease activity (DAS-28, ASDAS, EVA, number of swollen joints, number of painful joint, nocturnal pain, morning stiffness)Patients in the third group will correspond to those with spondyloarthritis according ACR criteria |
| Controls | – | Other: Dietary Questionnaire, Other: Evaluation of disease activity (DAS-28, ASDAS, EVA, number of swollen joints, number of painful joint, nocturnal pain, morning stiffness)Patients without rheumatic disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic rheumatological diseases (spondylitis, rheumatoid arthritis, osteoarthritis) and control population (also followed for any other pathology in the department).
Key inclusion criteria (3 listed)
- Age > 18 years
- chronic rheumatic disease (Rheumatoid arthritis, spondyloarthritis, osteoarthritis)
- ability to perform questionnaires
Key exclusion criteria (3 listed)
- Judicial protection measure
- Refusal to participate in the study
- Suffering from 2 rheumatic disease simultaneously
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary QuestionnaireSelf administered dietary questionnaire at baseline, 6 and 12 months. | Other | 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)Self administered questionnaire of disease activity at baseline, 6 and 12 months. | Other | Controls, Osteoarthritis, Rheumatoid Arthritis, Spondyloarthritis |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maxime AUROUX, MD principal investigator
Hôpital Edouard Herriot
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Spondyloarthritis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxime AUROUX, MD (+33472117479, Maxime.auroux@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the consumption of ultra-processed foods in patients with chronic inflammatory rheumatism (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.