Skip to content

Postprandial Inflammation in Rheumatoid Arthritis

Postprandial Inflammation in Rheumatoid Arthritis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04247009
Acronym
PIRA
Enrollment
56
Registered
2020-01-29
Start date
2020-02-01
Completion date
2021-11-17
Last updated
2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

postprandial, inflammation, rheumatoid arthritis, RA, diet, PIRA

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.

Interventions

OTHERMeal based on red meat, fish products or vegan products

Three meals will be served

OTHERMeal based on red meat

Matched Controls will be served only one meal of meat to compare response between (non-RA) matched controls and patients with RA

Sponsors

Sahlgrenska University Hospital
CollaboratorOTHER
Göteborg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Masking description

All data will be given a new code Before statistical analysis to mask treatment (study meal or Control) to the outcome assessor

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Circulating interleukin 6From baseline up to 5 hours postprandialChanges from fasting to postprandial
Circulating high sensitive C-reactive protein (CRP)From baseline up to 5 hours postprandialChanges from fasting to 5 hours postprandial, area under curve
Circulating triacylglyceridesFrom baseline up to 5 hours postprandialBlood lipid levels, Area Under curve from fasting to 5 hours postprandial
Gene expression analysisFrom baseline up to 5 hours postprandialChanges in gene expressions related to inflammation and disease activity in peripheral blood mononuclear cells
Serum metabolomicsFrom baseline up to 5 hours postprandialPatterns of nuclear magnetic resonance (NMR) analysis of metabolites, analysis of several timepoints separately
Urine metabolomicsFrom baseline up to 5 hours postprandialPatterns of nuclear magnetic resonance (NMR) analysis of metabolites,analysis of several timepoints separately

Secondary

MeasureTime frameDescription
Patient-reported dietary intakeThrough study completion, expected to be complete within 1 yearmeasured by food frequency questionnaire and 4-day food diary
Body compositionMeasured at inclusion of trial, expected to be complete within 6 monthsMeasured by dual energy X-ray technology
Patient-reported disabilityDuring trial, expected to be complete within 1 yearHealth Assessment Questionnaire, disability index (HAQ)
Patient-reported background and dietary habitsDuring trial, expected to be complete within 1 yearMeasured by questionnaire about socioeconomic status and changes in dietary habits related to perceived health
Resting metabolic ratethrough study completion, expected within 1 yearmeasured by indirect calorimetry
GlucoseFrom baseline up to 5 hours postprandialblood glucose levels measured by NMR-analysis
InsulinFrom baseline up to 5 hours postprandialblood insulin levels measured by NMR-analysis
Patient-reported quality of lifethrough study completion, expected to be complete within 1 yearMeasured by EQ5D-5L questionnaire
Patient-reported healththrough study completion, expected to be complete within 1 yearMeasured by the Short Form (SF36) questionnaire

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026