Mussels, Inflammation and Rheumatoid Arthritis (MIRA)

NCT02522052 | Completed

• 1 other identifier: MIRA
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

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

  Measured clinically

  after 11 week intervention

Secondary Outcomes (3)

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

  after 11 week intervention

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

  after 11 week intervention

• Differences and changes in metabolites after the two diets

  after 11 week intervention

Other Outcomes (5)

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

  after 11 week intervention

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

  after 11 week intervention

• Differences in Hb after the diets

  after 11 week intervention

Study Arms (2)

Blue mussel diet

EXPERIMENTAL

5 meals a week including blue mussels

Other: Blue mussel diet

Meat/control diet

ACTIVE COMPARATOR

5 meals a week including meat

Other: Meat/Control diet

Interventions

Blue mussel diet OTHER

5 meals a week containing blue mussels

Blue mussel diet

Meat/Control diet OTHER

5 meals a week containing meat

Meat/control diet

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Göteborg University: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Sahlgrenska University Hospital

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

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Helen M Lindqvist, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2015
• First Posted: August 13, 2015
• Study Start: August 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)