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Completed

NCT Number: NCT02522052

Mussels, Inflammation and Rheumatoid Arthritis (MIRA)

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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Key information

Age range

25 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, Not in US/Canada, 405 30, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blue mussel diet

Other

5 meals a week containing blue mussels

Meat/Control diet

Other

5 meals a week containing meat

Primary outcomes

  1. difference between disease activity score 28 (DAS28) after the diets

    Time frame: after 11 week intervention

    Measured clinically

Secondary outcomes

  1. difference in inflammatory markers/cytokines (IL-1beta, IL-6, Tumor Necrosis Factor-alfa, IL-10) after the diets

    Time frame: after 11 week intervention

    measured in blood

  2. Difference in Quality of life and health by SF36, EQ5D och HAQ after the diets

    Time frame: after 11 week intervention

    Measured by validated instruments (SF36, EQ5D och HAQ)

  3. Differences and changes in metabolites after the two diets

    Time frame: after 11 week intervention

    Metabolomics Nuclear magnetic resonance (NMR) analysis of serum and urin samples.

Other outcomes

  1. Difference in plasma and RBC fatty acids after the diets and changes during the diets

    Time frame: after 11 week intervention

    Fatty acids in plasma and red blood cells (RBC)

  2. Differences between blood lipids (TAG, HDL, LDL) after the diets

    Time frame: after 11 week intervention

    Serum analysis of TAG, HDL, LDL

  3. Differences in Hb after the diets

    Time frame: after 11 week intervention

    Blood status (Hb)

  4. Eular response criteria

    Time frame: after 11 week intervention

    To interpret effects on DAS28

  5. Stable isotopes in hair

    Time frame: after 11 week intervention

    stable isotopes

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Sahlgrenska University Hospital

Registry information

Acronym: MIRA

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 13, 2015
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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