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Mussels, Inflammation and Rheumatoid Arthritis (MIRA)

Mussels, Inflammation and Rheumatoid Arthritis (MIRA)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02522052
Acronym
MIRA
Enrollment
23
Registered
2015-08-13
Start date
2015-08-31
Completion date
2016-05-31
Last updated
2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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).

Interventions

OTHERBlue mussel diet

5 meals a week containing blue mussels

OTHERMeat/Control diet

5 meals a week containing meat

Sponsors

Sahlgrenska University Hospital
CollaboratorOTHER
Göteborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
difference between disease activity score 28 (DAS28) after the dietsafter 11 week interventionMeasured clinically

Secondary

MeasureTime frameDescription
difference in inflammatory markers/cytokines (IL-1beta, IL-6, Tumor Necrosis Factor-alfa, IL-10) after the dietsafter 11 week interventionmeasured in blood
Difference in Quality of life and health by SF36, EQ5D och HAQ after the dietsafter 11 week interventionMeasured by validated instruments (SF36, EQ5D och HAQ)
Differences and changes in metabolites after the two dietsafter 11 week interventionMetabolomics Nuclear magnetic resonance (NMR) analysis of serum and urin samples.

Other

MeasureTime frameDescription
Differences in Hb after the dietsafter 11 week interventionBlood status (Hb)
Differences between blood lipids (TAG, HDL, LDL) after the dietsafter 11 week interventionSerum analysis of TAG, HDL, LDL
Eular response criteriaafter 11 week interventionTo interpret effects on DAS28
Stable isotopes in hairafter 11 week interventionstable isotopes
Difference in plasma and RBC fatty acids after the diets and changes during the dietsafter 11 week interventionFatty acids in plasma and red blood cells (RBC)

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026