Postprandial Inflammation in Rheumatoid Arthritis

Study Overview
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Brief Summary
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Patients with RA will be studied to see whether meals of different content will affect inflammation and metabolic variables in the postprandial state. Healthy controls will also be invited to examine potentially different responses to patients with RA.

Detailed Description
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The PIRA study aims to evaluate the metabolic and inflammatory effects after a vegan meal or a meal containing red meat or fish in patients with RA and matched controls. The study have a cross-over design and each participant will have one of three meals every week and then be compared to themselves. In addition healthy individuals will be included for the red meat meal so that the response from this meal could be compared between patients with RA and their matched controls. Blood samples will be collected before the meal (fasting) and every hour until 5h. Primary outcome will be high sensitive IL-6. Secondary outcomes will be additional inflammation markers such as area under curve for hs-CRP and gene expression in PBMC:s regarding genes related to inflammation and, glucose, blood lipids and metabolomics-profile in serum and urine.

Official Title
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Postprandial Inflammation in Rheumatoid Arthritis

Conditions
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Arthritis, Rheumatoid, Inflammatory Response, Dietary Exposure, Diet, Healthy

Intervention / Treatment
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* Other: Meal based on red meat, fish products or vegan products
* Other: Meal based on red meat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for patients with RA: Diagnosed with rheumatoid arthritis BMI 18.5-30.0 kg/m2 2 years or more since diagnosis No DMARD changes during the last 3 months Inclusion Criteria for healthy controls: Absence of diagnosis of RA BMI 18.5-30.0 kg/m2 Self-assessed as healthy Exclusion Criteria: Diagnosis of cancer, inflammatory bowel disease, celiac disease, diabetes Allergy or intolerance to any of the foods in the study Pregnancy or breastfeeding Use of any blood lipid lowering medication, glucocorticoids or IL-6-inhibitor during the last 4 weeks prior to enrolment Smoking Hemoglobin < 100 g/L

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Meat<br>Patients with RA served a meal of meat | Other: Meal based on red meat, fish products or vegan products<br>* Three meals will be served<br>Other: Meal based on red meat<br>* Matched Controls will be served only one meal of meat to compare response between (non-RA) matched controls and patients with RA<br>|
| Active Comparator: Fish<br>Patients with RA served a meal of fish | Other: Meal based on red meat, fish products or vegan products<br>* Three meals will be served<br>|
| Active Comparator: Vegan<br>Patients with RA served a vegan meal | Other: Meal based on red meat, fish products or vegan products<br>* Three meals will be served<br>|
| Active Comparator: Meat controls<br>Matched controls served a meal of meat | Other: Meal based on red meat<br>* Matched Controls will be served only one meal of meat to compare response between (non-RA) matched controls and patients with RA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating interleukin 6 | Changes from fasting to postprandial | From baseline up to 5 hours postprandial | 
| Circulating high sensitive C-reactive protein (CRP) | Changes from fasting to 5 hours postprandial, area under curve | From baseline up to 5 hours postprandial | 
| Circulating triacylglycerides | Blood lipid levels, Area Under curve from fasting to 5 hours postprandial | From baseline up to 5 hours postprandial | 
| Gene expression analysis | Changes in gene expressions related to inflammation and disease activity in peripheral blood mononuclear cells | From baseline up to 5 hours postprandial | 
| Serum metabolomics | Patterns of nuclear magnetic resonance (NMR) analysis of metabolites, analysis of several timepoints separately | From baseline up to 5 hours postprandial | 
| Urine metabolomics | Patterns of nuclear magnetic resonance (NMR) analysis of metabolites,analysis of several timepoints separately | From baseline up to 5 hours postprandial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Measured by dual energy X-ray technology | Measured at inclusion of trial, expected to be complete within 6 months | 
| Body composition | measured by electric impedance analysis | Measured at inclusion and during trial, expected to be complete within 1 year | 
| Resting metabolic rate | measured by indirect calorimetry | through study completion, expected within 1 year | 
| Glucose | blood glucose levels measured by NMR-analysis | From baseline up to 5 hours postprandial | 
| Insulin | blood insulin levels measured by NMR-analysis | From baseline up to 5 hours postprandial | 
| Patient-reported quality of life | Measured by EQ5D-5L questionnaire | through study completion, expected to be complete within 1 year | 
| Patient-reported health | Measured by the Short Form (SF36) questionnaire | through study completion, expected to be complete within 1 year | 
| Patient-reported dietary intake | measured by food frequency questionnaire and 4-day food diary | Through study completion, expected to be complete within 1 year | 
| Patient-reported background and dietary habits | Measured by questionnaire about socioeconomic status and changes in dietary habits related to perceived health | During trial, expected to be complete within 1 year | 
| Patient-reported disability | Health Assessment Questionnaire, disability index (HAQ) | During trial, expected to be complete within 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RA, postprandial, inflammation, rheumatoid arthritis, diet, PIRA