Mussels, Inflammation and Rheumatoid Arthritis (MIRA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation
Study type: Interventional

Summary: 
      Rheumatoid arthritis (RA) is a chronic disease that affects ~1% of the population. A large
      proportion of patients with established disease have persistent high disease activity in
      spite of existing effective pharmacological treatment. Improved treatment is thus urgently
      needed, including alternative treatments in addition to optimal pharmacological therapy. The
      main purpose of this study is to investigate if a high intake of blue mussel (Mytilus Edulis)
      could decrease inflammation and disease activity in patients with established RA. A secondary
      goal is to identify novel biomarkers for blue mussel intake and metabolic responses to this
      diet, using a metabolomics approach with high sensitivity and specificity. A third goal is to
      look at genetic polymorphisms in relation to long chain polyunsaturated fatty acids (LCPUFA)
      and inflammatory markers.
    

Detailed description: 
      Rheumatoid arthritis (RA) is a chronic disease that affects ~1% of the population. A large
      proportion of patients with established disease have persistent high disease activity in
      spite of existing effective pharmacological treatment. Improved treatment is thus urgently
      needed, including alternative treatments in addition to optimal pharmacological therapy. The
      main purpose of this study is to investigate if a high intake of blue mussel (Mytilus Edulis)
      could decrease inflammation and disease activity in patients with established RA. A secondary
      goal is to identify novel biomarkers for blue mussel intake and metabolic responses to this
      diet, using a metabolomics approach with high sensitivity and specificity. A third goal is to
      look at genetic polymorphisms in relation to LCPUFA and inflammatory markers.

      Diet and lifestyle are associated with chronic diseases such as cardiovascular diseases,
      cancer and diabetes. Here, evidence based dietary treatment guidelines are available. In
      contrast, for inflammatory diseases such as RA no dietary guidelines exist, reflecting the
      ambiguous evidence base. Many dietary components are related to the human immune system or to
      inflammation. Some are co-factors in immune- or inflammatory response, such as zinc. Others
      are antioxidants, eg selenium, vitamins E and C. RA has been associated with low serum
      concentrations of zinc, selenium, vitamins D and B6 although some of this may reflect
      inflammatory response. Dietary effects on RA symptoms have been reported for long chain fatty
      acids from fish and probiotics have shown to improve function in RA patients. As prebiotics
      reduce inflammation in other conditions, it may have positive effects also on RA. Most
      research on antioxidants has focused on single nutrients but a few dietary trials also have
      been conducted with mixed results. In sum, high-quality studies evaluating the effect of a
      combination of food items with indicative effects on RA are needed.

      Blue mussels are rich in vitamins (B2 and B12) and minerals (iron, selenium and zinc) and
      contain the LCPUFA eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
    

Intervention name(s): Blue mussel diet; Meat/Control diet
Intervention type(s): Other; Other
Intervention description(s): 5 meals a week containing blue mussels; 5 meals a week containing meat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment