Sahlgrenska University Hospital
Gothenburg, Not in US/Canada, 405 30, Sweden
NCT Number: NCT04247009
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.
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Notify Me20 year–70 year
Female
Interventional
Not applicable
Gothenburg, Not in US/Canada, 405 30, Sweden
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for patients with RA:
Inclusion criteria
for healthy controls:
Exclusion criteria
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
Time frame: From baseline up to 5 hours postprandial
Changes from fasting to postprandial
Time frame: From baseline up to 5 hours postprandial
Changes from fasting to 5 hours postprandial, area under curve
Time frame: From baseline up to 5 hours postprandial
Blood lipid levels, Area Under curve from fasting to 5 hours postprandial
Time frame: From baseline up to 5 hours postprandial
Changes in gene expressions related to inflammation and disease activity in peripheral blood mononuclear cells
Time frame: From baseline up to 5 hours postprandial
Patterns of nuclear magnetic resonance (NMR) analysis of metabolites, analysis of several timepoints separately
Time frame: From baseline up to 5 hours postprandial
Patterns of nuclear magnetic resonance (NMR) analysis of metabolites,analysis of several timepoints separately
Time frame: Measured at inclusion of trial, expected to be complete within 6 months
Measured by dual energy X-ray technology
Time frame: Measured at inclusion and during trial, expected to be complete within 1 year
measured by electric impedance analysis
Time frame: through study completion, expected within 1 year
measured by indirect calorimetry
Time frame: From baseline up to 5 hours postprandial
blood glucose levels measured by NMR-analysis
Time frame: From baseline up to 5 hours postprandial
blood insulin levels measured by NMR-analysis
Time frame: through study completion, expected to be complete within 1 year
Measured by EQ5D-5L questionnaire
Time frame: through study completion, expected to be complete within 1 year
Measured by the Short Form (SF36) questionnaire
Time frame: Through study completion, expected to be complete within 1 year
measured by food frequency questionnaire and 4-day food diary
Time frame: During trial, expected to be complete within 1 year
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
Health Assessment Questionnaire, disability index (HAQ)
Göteborg University
Other
Acronym: PIRA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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