RecruitingNot ApplicableNCT06305936

Feasibility Study: Plant Based Diet to Patients With Rheumatoid Arthritis

The Feasibility and Acceptability of a Plant-Based Diet in People With Rheumatoid Arthritis - A Randomized Feasibility Study


Sponsor

Bispebjerg Hospital

Enrollment

30 participants

Start Date

Feb 15, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

In this feasibility study, our primary goal is to assess the practicality of implementing a plant-based food diet intervention for individuals with rheumatoid arthritis (RA). The intervention consists of three key components: 1) Educational materials (videos), 2) Participation in a cooking workshop introducing plant-based meals, complete with recipes, and 3) Daily delivery of plant-based dinner meals over a four-week period. This comprehensive investigation covers the testing of recruitment procedures, randomization, intervention elements, outcome assessments, and participant retention. Adopting a daily plant-based diet involves introducing several new plant-based foods and making adjustments to the existing diets of patients with RA. Consequently, the feasibility study will also aim to explore the acceptability of the intervention and whether a full-scale RCT is practically possible.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria11

  • 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

Interventions

OTHERIntervention with 100% plant-based diet

The intervention consists of three key components: 1) Educational materials (videos), 2) Participation in a cooking workshop introducing plant-based meals, complete with recipes, and 3) Daily delivery of plant-based dinner meals over a four-week period. The remaining meals during the period are modified by the participant to also adhere to a 100% plant-based composition.


Locations(2)

Center for Clinical Research and Prevention, BispebjergH

Frederiksberg, Denmark

The Department of Rheumatology and Spine Diseases, Copenhagen Center for Arthritis Research (COPECARE), Rigshospitalet, Glostrup

Glostrup Municipality, Denmark

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NCT06305936


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