Clinical trial NCT02522052: Mussels, Inflammation and Rheumatoid Arthritis (MIRA)
Official title: Mussels, Inflammation and Rheumatoid Arthritis (MIRA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
First posted: 2015-08-13
Enrollment: 23
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion Criteria:

* BMI 18-40 kg/m2,
* disease duration \>2 years,
* DAS28 \>3.0

Exclusion Criteria:

* other Life-threatening disease,
* pregnant,
* lactating,
* food intolerant or allergic to food included in the study.

Primary outcomes:
measure: difference between disease activity score 28 (DAS28) after the diets
timeFrame: after 11 week intervention
Secondary outcomes:
measure: difference in inflammatory markers/cytokines (IL-1beta, IL-6, Tumor Necrosis Factor-alfa, IL-10) after the diets
timeFrame: after 11 week intervention
measure: Difference in Quality of life and health by SF36, EQ5D och HAQ after the diets
timeFrame: after 11 week intervention
measure: Differences and changes in metabolites after the two diets
timeFrame: after 11 week intervention
Other outcomes:
measure: Difference in plasma and RBC fatty acids after the diets and changes during the diets
timeFrame: after 11 week intervention
measure: Differences between blood lipids (TAG, HDL, LDL) after the diets
timeFrame: after 11 week intervention
measure: Differences in Hb after the diets
timeFrame: after 11 week intervention
measure: Eular response criteria
timeFrame: after 11 week intervention
measure: Stable isotopes in hair
timeFrame: after 11 week intervention
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
state: Not In US/Canada
Study officials:
affiliation: Göteborg University
name: Helen M Lindqvist, PhD
role: PRINCIPAL_INVESTIGATOR
References: