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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
56
Three meals will be served
Matched Controls will be served only one meal of meat to compare response between (non-RA) matched controls and patients with RA
Sahlgrenska University Hospital
Gothenburg, Not in US/Canada, Sweden
Circulating interleukin 6
Changes from fasting to postprandial
Time frame: From baseline up to 5 hours postprandial
Circulating high sensitive C-reactive protein (CRP)
Changes from fasting to 5 hours postprandial, area under curve
Time frame: From baseline up to 5 hours postprandial
Circulating triacylglycerides
Blood lipid levels, Area Under curve from fasting to 5 hours postprandial
Time frame: 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
Time frame: From baseline up to 5 hours postprandial
Serum metabolomics
Patterns of nuclear magnetic resonance (NMR) analysis of metabolites, analysis of several timepoints separately
Time frame: From baseline up to 5 hours postprandial
Urine metabolomics
Patterns of nuclear magnetic resonance (NMR) analysis of metabolites,analysis of several timepoints separately
Time frame: From baseline up to 5 hours postprandial
Body composition
Measured by dual energy X-ray technology
Time frame: Measured at inclusion of trial, expected to be complete within 6 months
Body composition
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measured by electric impedance analysis
Time frame: Measured at inclusion and during trial, expected to be complete within 1 year
Resting metabolic rate
measured by indirect calorimetry
Time frame: through study completion, expected within 1 year
Glucose
blood glucose levels measured by NMR-analysis
Time frame: From baseline up to 5 hours postprandial
Insulin
blood insulin levels measured by NMR-analysis
Time frame: From baseline up to 5 hours postprandial
Patient-reported quality of life
Measured by EQ5D-5L questionnaire
Time frame: through study completion, expected to be complete within 1 year
Patient-reported health
Measured by the Short Form (SF36) questionnaire
Time frame: through study completion, expected to be complete within 1 year
Patient-reported dietary intake
measured by food frequency questionnaire and 4-day food diary
Time frame: 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
Time frame: During trial, expected to be complete within 1 year
Patient-reported disability
Health Assessment Questionnaire, disability index (HAQ)
Time frame: During trial, expected to be complete within 1 year