Sahlgrenska University Hospital
Gothenburg, Not in US/Canada, 405 30, Sweden
NCT Number: NCT02522052
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.
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Notify Me25 year–65 year
Female
Interventional
Not applicable
Gothenburg, Not in US/Canada, 405 30, Sweden
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5 meals a week containing blue mussels
5 meals a week containing meat
Time frame: after 11 week intervention
Measured clinically
Time frame: after 11 week intervention
measured in blood
Time frame: after 11 week intervention
Measured by validated instruments (SF36, EQ5D och HAQ)
Time frame: after 11 week intervention
Metabolomics Nuclear magnetic resonance (NMR) analysis of serum and urin samples.
Time frame: after 11 week intervention
Fatty acids in plasma and red blood cells (RBC)
Time frame: after 11 week intervention
Serum analysis of TAG, HDL, LDL
Time frame: after 11 week intervention
Blood status (Hb)
Time frame: after 11 week intervention
To interpret effects on DAS28
Time frame: after 11 week intervention
stable isotopes
Göteborg University
Other
Acronym: MIRA
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