Mussels, Inflammation and Rheumatoid Arthritis (MIRA) (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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Other: Blue mussel diet; Other: Meat/Control diet

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).

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Not In US/Canada
    • Göteborg, Not In US/Canada, Sweden, 405 30
      • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blue mussel diet; 5 meals a week including blue mussels	Other: Blue mussel diet; 5 meals a week containing blue mussels
Active Comparator: Meat/control diet; 5 meals a week including meat	Other: Meat/Control diet; 5 meals a week containing meat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
difference between disease activity score 28 (DAS28) after the diets	Measured clinically	after 11 week intervention

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Sahlgrenska University Hospital, Sweden
• Investigators: Principal Investigator: Helen M Lindqvist, PhD, Göteborg University

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: April 29, 2015
• First Submitted That Met QC Criteria: August 11, 2015
• First Posted (Estimated): August 13, 2015

Study Record Updates

• Last Update Posted (Actual): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathologic Processes; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Inflammation; Arthritis, Rheumatoid
• Other Study ID Numbers: MIRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not approved by the Ethical Review board