Mussels, Inflammation and Rheumatoid Arthritis (MIRA) (MIRA)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Blue mussel diet
Meat/Control diet
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
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.
Sites / Locations
- Sahlgrenska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Blue mussel diet
Meat/control diet
Arm Description
5 meals a week including blue mussels
5 meals a week including meat
Outcomes
Primary Outcome Measures
difference between disease activity score 28 (DAS28) after the diets
Measured clinically
Secondary Outcome Measures
difference in inflammatory markers/cytokines (IL-1beta, IL-6, Tumor Necrosis Factor-alfa, IL-10) after the diets
measured in blood
Difference in Quality of life and health by SF36, EQ5D och HAQ after the diets
Measured by validated instruments (SF36, EQ5D och HAQ)
Differences and changes in metabolites after the two diets
Metabolomics Nuclear magnetic resonance (NMR) analysis of serum and urin samples.
Full Information
NCT ID
NCT02522052
First Posted
April 29, 2015
Last Updated
August 14, 2017
Sponsor
Göteborg University
Collaborators
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT02522052
Brief Title
Mussels, Inflammation and Rheumatoid Arthritis (MIRA)
Acronym
MIRA
Official Title
Mussels, Inflammation and Rheumatoid Arthritis (MIRA)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Sahlgrenska University Hospital, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blue mussel diet
Arm Type
Experimental
Arm Description
5 meals a week including blue mussels
Arm Title
Meat/control diet
Arm Type
Active Comparator
Arm Description
5 meals a week including meat
Intervention Type
Other
Intervention Name(s)
Blue mussel diet
Intervention Description
5 meals a week containing blue mussels
Intervention Type
Other
Intervention Name(s)
Meat/Control diet
Intervention Description
5 meals a week containing meat
Primary Outcome Measure Information:
Title
difference between disease activity score 28 (DAS28) after the diets
Description
Measured clinically
Time Frame
after 11 week intervention
Secondary Outcome Measure Information:
Title
difference in inflammatory markers/cytokines (IL-1beta, IL-6, Tumor Necrosis Factor-alfa, IL-10) after the diets
Description
measured in blood
Time Frame
after 11 week intervention
Title
Difference in Quality of life and health by SF36, EQ5D och HAQ after the diets
Description
Measured by validated instruments (SF36, EQ5D och HAQ)
Time Frame
after 11 week intervention
Title
Differences and changes in metabolites after the two diets
Description
Metabolomics Nuclear magnetic resonance (NMR) analysis of serum and urin samples.
Time Frame
after 11 week intervention
Other Pre-specified Outcome Measures:
Title
Difference in plasma and RBC fatty acids after the diets and changes during the diets
Description
Fatty acids in plasma and red blood cells (RBC)
Time Frame
after 11 week intervention
Title
Differences between blood lipids (TAG, HDL, LDL) after the diets
Description
Serum analysis of TAG, HDL, LDL
Time Frame
after 11 week intervention
Title
Differences in Hb after the diets
Description
Blood status (Hb)
Time Frame
after 11 week intervention
Title
Eular response criteria
Description
To interpret effects on DAS28
Time Frame
after 11 week intervention
Title
Stable isotopes in hair
Description
stable isotopes
Time Frame
after 11 week intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen M Lindqvist, PhD
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Göteborg
State/Province
Not in US/Canada
ZIP/Postal Code
405 30
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not approved by the Ethical Review board
Learn more about this trial
Mussels, Inflammation and Rheumatoid Arthritis (MIRA)
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