ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis)

Study Overview
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Brief Summary
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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
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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.

Official Title
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ADIRA (Anti-inflammatory Diet In Rheumatoid Arthritis)

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Other: Fiber diet
* Other: Protein diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with established RA, disease duration >2 years, disease activity DAS28 >= 2.6 and a disease that is clinically stable and under adequate control and medication, will be invited to participate. Exclusion Criteria: Other life threatening diseases, pregnancy, lactation, food intolerance or allergy to food included in the trial, ability to understand information in Swedish

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fiber diet<br>50% of daily intake, 5 days a week, a diet rich in fiber, fish and probiotics will be provided to study subjects | Other: Fiber diet<br>* Foods will be delivered with a home delivery chain once a week for 10 wks of each diet<br>|
| Active Comparator: Protein diet<br>50% of daily intake, 5 days a week, a diet rich in protein, red meat and saturated fat will be provided to study subjects | Other: Protein diet<br>* Foods will be delivered with a home delivery chain once a week for 10 wks of each diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 10 weeks of each diet | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in SF-36 between the two diet interventions, within each person | Measured by validated instruments | 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 | 10 weeks on each diet | 
| Differences in inflammatory markers between the two diet interventions, within each person | hs-CRP, cytokines in blood | 10 weeks on each diet | 
| Difference in EQ5D between the two diet interventions, within each person | Measured by validated instruments | 10 weeks on each diet | 
| Difference in HAQ between the two diet interventions, within each person | Measured by validated instruments | 10 weeks on each diet | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Inflammation, Metabolomics