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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
56
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
The University of Gothenburg
Gothenburg, Sweden
Difference in disease activity score DAS28 (ie a composite score including tender and swollen joints count, ESR or CRP, VAS scale global health) between the two diet interventions, within each person
Measured clinically
Time frame: 10 weeks of each diet
Difference in SF-36 between the two diet interventions, within each person
Measured by validated instruments
Time frame: 10 weeks on each diet
Difference and changes in metabolites between the two diet interventions, within each person
Metabolomics with NMR and MS analyses of serum and urine samples
Time frame: 10 weeks on each diet
Differences in inflammatory markers between the two diet interventions, within each person
hs-CRP, cytokines in blood
Time frame: 10 weeks on each diet
Difference in EQ5D between the two diet interventions, within each person
Measured by validated instruments
Time frame: 10 weeks on each diet
Difference in HAQ between the two diet interventions, within each person
Measured by validated instruments
Time frame: 10 weeks on each diet
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