Plant-based diet intervention for rheumatoid arthritis patients
The Feasibility and Acceptability of a Plant-Based Diet in People With Rheumatoid Arthritis - A Randomized Feasibility Study
This study is testing whether a plant-based diet can help people with rheumatoid arthritis feel better by providing them with meals and cooking workshops over four weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bispebjerg Hospital Academic / other |
| Locations | 2 sites (Frederiksberg and 1 other locations) |
| Trial ID | NCT06305936 on ClinicalTrials.gov |
What this trial studies
This feasibility study aims to evaluate the practicality of implementing a plant-based diet intervention for individuals with rheumatoid arthritis (RA). The intervention includes educational materials, a cooking workshop for plant-based meals, and daily delivery of plant-based dinners over four weeks. The study will assess recruitment procedures, randomization, intervention elements, outcome assessments, and participant retention, while also exploring the acceptability of the intervention. Ultimately, the goal is to lay the groundwork for a larger randomized controlled trial to test the effects of a plant-based diet on RA disease activity.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with rheumatoid arthritis for at least one year, with a Disease Activity Score between 2.0 and 3.2, and stable on their current medication.
Not a fit: Patients who are daily smokers, have diabetes, are pregnant or lactating, or have dietary habits similar to the intervention diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved disease management and quality of life for patients with rheumatoid arthritis.
How similar studies have performed: While this approach is novel in the context of rheumatoid arthritis, previous studies have shown positive outcomes with lifestyle interventions focusing on diet and physical activity.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Disease Activity Score with 28 Joint Counts (DAS28) between 2.0-3.2 * A rheumatoid arthritis diagnosis of minimum 1 year * Under stable pharmaceutical treatment for at least 4 months and with no planned change in treatment within 8 weeks Exclusion Criteria: * Daily smokers * Diabetes Mellitus * Pregnancy / planned pregnancy * Lactation * Prednisolone treatment * DAS28 below 2.0 and above 3.2 * Current dietary habits resembling intervention diet (e.g., 100% plant based diets) * Participation in other intervention studies or clinical trials via the rheumatology outpatient clinic that will affect their adherence to plant based diets * Not able to eat ad libitum meals because of e.g., allergy * Unable to understand the informed consent and study procedures * Alcohol and/or drug abuse
Where this trial is running
Frederiksberg and 1 other locations
- Center for Clinical Research and Prevention, BispebjergH — Frederiksberg, Denmark (Active_not_recruiting)
- The Department of Rheumatology and Spine Diseases, Copenhagen Center for Arthritis Research (COPECARE), Rigshospitalet, Glostrup — Glostrup, Denmark (Recruiting)
Study contacts
- Principal investigator: Allan Linneberg, Ph.D. — Bispebjerg Hospital
- Study coordinator: Kirsten Schroll Bjørnsbo, Ph.D.
- Email: Kirsten.bjoernsbo@regionh.dk
- Phone: +4520169134
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.