Postprandial Inflammation in Rheumatoid Arthritis
- Conditions
- Inflammatory ResponseDietary ExposureArthritis, RheumatoidDiet, Healthy
- Registration Number
- NCT04247009
- Lead Sponsor
- Göteborg University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 56
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Urine metabolomics From baseline up to 5 hours postprandial Patterns of nuclear magnetic resonance (NMR) analysis of metabolites,analysis of several timepoints separately
Serum metabolomics From baseline up to 5 hours postprandial Patterns of nuclear magnetic resonance (NMR) analysis of metabolites, analysis of several timepoints separately
Circulating interleukin 6 From baseline up to 5 hours postprandial Changes from fasting to postprandial
Circulating high sensitive C-reactive protein (CRP) From baseline up to 5 hours postprandial Changes from fasting to 5 hours postprandial, area under curve
Gene expression analysis From baseline up to 5 hours postprandial Changes in gene expressions related to inflammation and disease activity in peripheral blood mononuclear cells
Circulating triacylglycerides From baseline up to 5 hours postprandial Blood lipid levels, Area Under curve from fasting to 5 hours postprandial
- Secondary Outcome Measures
Name Time Method Patient-reported quality of life through study completion, expected to be complete within 1 year Measured by EQ5D-5L questionnaire
Resting metabolic rate through study completion, expected within 1 year measured by indirect calorimetry
Insulin From baseline up to 5 hours postprandial blood insulin levels measured by NMR-analysis
Patient-reported health through study completion, expected to be complete within 1 year Measured by the Short Form (SF36) questionnaire
Glucose From baseline up to 5 hours postprandial blood glucose levels measured by NMR-analysis
Patient-reported background and dietary habits During trial, expected to be complete within 1 year Measured by questionnaire about socioeconomic status and changes in dietary habits related to perceived health
Body composition Measured at inclusion and during trial, expected to be complete within 1 year measured by electric impedance analysis
Patient-reported dietary intake Through study completion, expected to be complete within 1 year measured by food frequency questionnaire and 4-day food diary
Patient-reported disability During trial, expected to be complete within 1 year Health Assessment Questionnaire, disability index (HAQ)
Trial Locations
- Locations (1)
Sahlgrenska University Hospital
🇸🇪Göteborg, Not In US/Canada, Sweden
Sahlgrenska University Hospital🇸🇪Göteborg, Not In US/Canada, Sweden