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| Name | Class |
|---|---|
| Sahlgrenska University Hospital | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blue mussel diet | Experimental | 5 meals a week including blue mussels |
|
| Meat/control diet | Active Comparator | 5 meals a week including meat |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blue mussel diet | Other | 5 meals a week containing blue mussels |
| |
| Measure | Description | Time Frame |
|---|---|---|
| difference between disease activity score 28 (DAS28) after the diets | Measured clinically | after 11 week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| difference in inflammatory markers/cytokines (IL-1beta, IL-6, Tumor Necrosis Factor-alfa, IL-10) after the diets | measured in blood | after 11 week intervention |
| Difference in Quality of life and health by SF36, EQ5D och HAQ after the diets |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in plasma and RBC fatty acids after the diets and changes during the diets | Fatty acids in plasma and red blood cells (RBC) | after 11 week intervention |
| Differences between blood lipids (TAG, HDL, LDL) after the diets |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen M Lindqvist, PhD | Göteborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | Not in US/Canada | 405 30 | Sweden |
Not approved by the Ethical Review board
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Meat/Control diet |
| Other |
5 meals a week containing meat |
|
Measured by validated instruments (SF36, EQ5D och HAQ)
| after 11 week intervention |
| Differences and changes in metabolites after the two diets | Metabolomics Nuclear magnetic resonance (NMR) analysis of serum and urin samples. | after 11 week intervention |
Serum analysis of TAG, HDL, LDL
| after 11 week intervention |
| Differences in Hb after the diets | Blood status (Hb) | after 11 week intervention |
| Eular response criteria | To interpret effects on DAS28 | after 11 week intervention |
| Stable isotopes in hair | stable isotopes | after 11 week intervention |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |