Plant-Based Diet for Patients With Rheumatoid Arthritis

NCT07268326 | Recruiting

• 1 other identifier: H-25045516
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Rheumatoid Arthritis (RA)

Keywords

Rheumatoid Arthritis; Plant-based; Dietary intervention; Clinical nutrition

Outcome Measures

Primary Outcomes (1)

• Disease activity measured by DAS28

  The Disease Activity Score 28 (DAS28) is a composite index used to assess disease activity in patients with rheumatoid arthritis. The DAS28 is a quantification of tender and swollen joints within the hands, shoulders, elbows, wrists, and knees. These assessments, in conjunction with CRP values obtained from blood samples and the self-reported global Visual Analog Scale (VAS) score, will be incorporated into the computation of DAS28. The DAS28 ranges from 0 to 10, with higher scores indicating higher disease activity.

  16 weeks

Secondary Outcomes (1)

• Ultrasound - supportive of the primary outcome

  16 weeks

Other Outcomes (18)

• Inflammatory biomarkers

  16 weeks

• Cholesterol

  16 weeks

• Glucose

  16 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Other: Plant-based diet

Control group

NO INTERVENTION

Interventions

Plant-based diet OTHER

The intervention is a 100% plant-based diet, and a daily multivitamin supplement. Participants in the intervention group will receive weekly food delivery to their household. Moreover, they will participate in a practical cooking workshop with other participants of the intervention group. Furthermore, they will have three online supervisions with relevant project staff.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: collaborator
• Center for Clinical Research and Prevention: lead

Study Sites (2)

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Diet, Plant-Based

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Nikita Misella Hansen, Postdoc

CONTACT

+4520661876; nikita.misella.hansen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Project nurses
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 5, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)