Plant-Based Diet for Patients With Rheumatoid Arthritis
Recruiting · NCT07268326 · Interventional (participants receive a specific treatment) · Lead sponsor: Center for Clinical Research and Prevention
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this clinical trial is to evaluate the effect of a plant-based diet (PBD) intervention in adults with Rheumatoid Arthritis (RA) on disease activity. The investigators hypothesize that if patients with RA follow a 100% PBD over a 16-week period it will lead to improvements in: \- Disease activity (measured by DAS28), including reduction in symptoms and overall improvements in health-related quality of life. The effects of the PBD will be compared to a habitual diet, that includes no dietary changes. Participants in the intervention group will: * Receive weekly delivery of food boxes which include plant-based food items * Receive a daily multivitamin supplement * Receive continuous dietetic guidance * Participate in a practical cooking class to get an introduction to a PBD * Participate in three online supervisions throughout the intervention period Participants in the control group will follow the same plan for the project visits at the hospital but will be restricted to continue their habitual diet. Thus, not performing any dietary changes.
Who can take part
Inclusion criteria
- Age ≥18 years
- DAS28 score ≤3.2, and without swollen joints
- RA diagnosis of minimum one year
- Stable pharmacological treatment for at least four months and with no planned change in treatment within eight weeks
Exclusion criteria
- Smokers
- Diabetes mellitus
- Pregnancy / planned pregnancy
- Prednisolone treatment
- DAS28 above 3.2
- Current dietary habits resembling intervention diet (e.g., PBD lifestyle)
- Food allergies and intolerances
- Unable to understand the informed consent and study procedures
Where it is running
2 locations listed.
- Bispebjerg and Frederiksberg Hospital, Center for Clinical Research and Prevention - Frederiksberg, Denmark
- The Department of Rheumatology and Spine Diseases, Copenhagen Center for Arthritis Research (COPECARE), Rigshospitalet, Glostrup - Glostrup Municipality, Denmark