An interventional study of Blue mussel diet and Meat/Control diet in Rheumatoid Arthritis, sponsored by Göteborg University. Completed at 1 site in Sweden. Open to female participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-19.
Sponsored by Göteborg University · Not applicable, Interventional, and Treatment
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).
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 23 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Göteborg University is the lead sponsor of 265 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
5 meals a week including blue mussels
Other: Blue mussel diet
5 meals a week including meat
Other: Meat/Control diet
5 meals a week containing blue mussels
5 meals a week containing meat
difference between disease activity score 28 (DAS28) after the diets
Measured clinically
Time frame: after 11 week intervention
difference in inflammatory markers/cytokines (IL-1beta, IL-6, Tumor Necrosis Factor-alfa, IL-10) after the diets
measured in blood
Time frame: after 11 week intervention
Difference in Quality of life and health by SF36, EQ5D och HAQ after the diets
Measured by validated instruments (SF36, EQ5D och HAQ)
Time frame: after 11 week intervention
Differences and changes in metabolites after the two diets
Metabolomics Nuclear magnetic resonance (NMR) analysis of serum and urin samples.
Time frame: after 11 week intervention
Difference in plasma and RBC fatty acids after the diets and changes during the diets
Fatty acids in plasma and red blood cells (RBC)
Time frame: after 11 week intervention
Differences between blood lipids (TAG, HDL, LDL) after the diets
Serum analysis of TAG, HDL, LDL
Time frame: after 11 week intervention
Differences in Hb after the diets
Blood status (Hb)
Time frame: after 11 week intervention
Eular response criteria
To interpret effects on DAS28
Time frame: after 11 week intervention
Stable isotopes in hair
stable isotopes
Time frame: after 11 week intervention
Plan to share: No — Not approved by the Ethical Review board
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Göteborg University