100% plant-based diet for adults with rheumatoid arthritis
PLATE: Health Effects of Plant-Based Diet in Patients With Rheumatoid Arthritis
This trial will test whether following a 100% plant-based diet for 16 weeks helps adults with rheumatoid arthritis lower disease activity, reduce symptoms, and improve quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Center for Clinical Research and Prevention Research network |
| Locations | 2 sites (Frederiksberg and 1 other locations) |
| Trial ID | NCT07268326 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial compares a 16-week 100% plant-based diet (PBD) intervention to participants' habitual diet in adults with rheumatoid arthritis. The intervention group receives weekly food box deliveries, a daily multivitamin, continuous dietetic guidance, a practical cooking class, and three online supervision sessions, while the control group continues their usual diet with the same visit schedule. Primary outcomes include change in disease activity measured by DAS28, with secondary outcomes covering cardio-metabolic health, physical function, mental health, sleep, and health-related quality of life. Eligible participants are adults with RA for at least one year, low disease activity (DAS28 ≤3.2) without swollen joints, and stable pharmacological treatment prior to enrollment.
Who should consider this trial
Good fit: Adults (≥18) with a physician-diagnosed RA for at least one year, low disease activity (DAS28 ≤3.2) without swollen joints, and on stable RA medication would be ideal candidates, provided they are not smokers, not diabetic, not pregnant, and not already following a plant-based diet.
Not a fit: Patients with higher disease activity (DAS28 >3.2), current prednisolone treatment, diabetes, pregnancy or planned pregnancy, smokers, those already on a plant-based diet, or with relevant food allergies/intolerances are unlikely to qualify or to gain benefit from this protocol.
Why it matters
Potential benefit: If successful, this could provide a practical dietary approach that lowers RA disease activity and improves symptoms and overall quality of life.
How similar studies have performed: Previous dietary interventions in RA have produced mixed results, and fully 100% plant-based diets have been only sparsely and inconclusively studied to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Frederiksberg and 1 other locations
- Bispebjerg and Frederiksberg Hospital, Center for Clinical Research and Prevention — Frederiksberg, Denmark (Recruiting)
- The Department of Rheumatology and Spine Diseases, Copenhagen Center for Arthritis Research (COPECARE), Rigshospitalet, Glostrup — Glostrup Municipality, Denmark (Recruiting)
Study contacts
- Study coordinator: Nikita Misella Hansen, Postdoc
- Email: nikita.misella.hansen@regionh.dk
- Phone: +4520661876
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.