ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects 0.5-1% of the
      population, and where many patients in spite of modern pharmacological treatment fail to
      reach remission. The main goal of the randomized cross-over trial ADIRA (Anti-inflammatory
      Diet In Rheumatoid Arthritis) is to test the hypothesis that a diet intervention will
      decrease disease activity and improve quality of life in patients with established RA.
    

Detailed description: 
      Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects 0.5-1% of the
      population, and where many patients in spite of modern pharmacological treatment fail to
      reach remission. This affects physical as well as mental wellbeing and leads to severely
      reduced quality of life and reduced work capacity, thus yielding high individual as well as
      societal costs. To optimize treatment, alternatives such as diet should be evaluated as
      complement to pharmacological treatment. The main goal of the randomized cross-over trial
      ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis) is to test the hypothesis that a diet
      intervention will decrease disease activity and costs and improve quality of life in patients
      with established RA. In total, 60 RA patients with moderate disease activity will be
      randomized to receive initially either a portfolio diet based on several food items with
      suggested anti-inflammatory effects or a control diet (western type), during 2 x 10 wks with
      a 3 months wash-out between diets. Both groups continue with regular pharmacological
      treatment. Known food biomarkers will be analyzed to measure intervention compliance. Impact
      on disease activity (measured by DAS28, a composite score which predicts disability and
      progression of RA) and quality of life is evaluated after each diet regimen. Metabolomics
      will be used to evaluate the potential to predict responders to dietary treatment. ADIRA will
      provide evidence whether dietary treatment of RA leads to more patients reaching remission
      and improved quality of life and work capacity as well as reduce individual and societal
      costs. Scientific evidence exists for anti-inflammatory effect by single foods on RA, but no
      study exists where these foods have been combined to obtain maximum effect and thus have the
      potential to offer a substantial improvement in patient life quality. Such evidence has been
      asked for by RA patents as well as by treating physicians.
    

Intervention name(s): Fiber diet; Protein diet
Intervention type(s): Other; Other
Intervention description(s): Foods will be delivered with a home delivery chain once a week for 10 wks of each diet; Foods will be delivered with a home delivery chain once a week for 10 wks of each diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diet; Inflammation; Metabolomics