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Plant-Based Diet for Patients With Rheumatoid Arthritis

ConditionRheumatoid Arthritis (RA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCenter for Clinical Research and Prevention

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Smokers

Diabetes mellitus

Pregnancy / planned pregnancy

Prednisolone treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Plant-based diet

    Other intervention

    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.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

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.

Time frame
16 weeks

Secondary outcomes

1

Ultrasound - supportive of the primary outcome

Ultrasound is performed bilaterally of the radio-carpal, inter-carpal and radio-ulna joint (with the highest of the 3 scores as the final score for the wrist joint), 1-5 metacarpophalangeal joint (MCP), 2-5 proximal interphalangeal joint (PIP), interphalangeal joint, ankle joint and 2-5 metatarsophalangeal joint (MTP).

Time frame
16 weeks

Other outcomes

1

Inflammatory biomarkers

Measured in blood samples, including: C-reactive protein (CRP), IL-6 and Soluble urokinase plasminogen activator receptor (suPAR).

Time frame
16 weeks
2

Cholesterol

Measured by blood samples: Total cholesterol, High-density lipoprotein , Low-density lipoprotein, Very-low density lipoprotein.

Time frame
16 weeks
3

Glucose

Blood samples of HbA1C

Time frame
16 weeks
4

Blood pressure

Blood pressure (systolic and diastolic) will be measured, after 5 to 10 minutes of rest with the participant in a sitting/lying position. The blood pressure will be measured three times at the right upper arm, and the average of the three measurements will be documented.

Time frame
16 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Center for Clinical Research and Prevention

Lead sponsor

Glostrup University Hospital, Copenhagen

Collaborator

Source ClinicalTrials.gov
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