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Completed

NCT Number: NCT04247009

Postprandial Inflammation in Rheumatoid Arthritis

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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Key information

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, Not in US/Canada, 405 30, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meal based on red meat, fish products or vegan products

Other

Three meals will be served

Meal based on red meat

Other

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

Primary outcomes

  1. Circulating interleukin 6

    Time frame: From baseline up to 5 hours postprandial

    Changes from fasting to postprandial

  2. Circulating high sensitive C-reactive protein (CRP)

    Time frame: From baseline up to 5 hours postprandial

    Changes from fasting to 5 hours postprandial, area under curve

  3. Circulating triacylglycerides

    Time frame: From baseline up to 5 hours postprandial

    Blood lipid levels, Area Under curve from fasting to 5 hours postprandial

  4. Gene expression analysis

    Time frame: From baseline up to 5 hours postprandial

    Changes in gene expressions related to inflammation and disease activity in peripheral blood mononuclear cells

  5. Serum metabolomics

    Time frame: From baseline up to 5 hours postprandial

    Patterns of nuclear magnetic resonance (NMR) analysis of metabolites, analysis of several timepoints separately

  6. Urine metabolomics

    Time frame: From baseline up to 5 hours postprandial

    Patterns of nuclear magnetic resonance (NMR) analysis of metabolites,analysis of several timepoints separately

Secondary outcomes

  1. Body composition

    Time frame: Measured at inclusion of trial, expected to be complete within 6 months

    Measured by dual energy X-ray technology

  2. Body composition

    Time frame: Measured at inclusion and during trial, expected to be complete within 1 year

    measured by electric impedance analysis

  3. Resting metabolic rate

    Time frame: through study completion, expected within 1 year

    measured by indirect calorimetry

  4. Glucose

    Time frame: From baseline up to 5 hours postprandial

    blood glucose levels measured by NMR-analysis

  5. Insulin

    Time frame: From baseline up to 5 hours postprandial

    blood insulin levels measured by NMR-analysis

  6. Patient-reported quality of life

    Time frame: through study completion, expected to be complete within 1 year

    Measured by EQ5D-5L questionnaire

  7. Patient-reported health

    Time frame: through study completion, expected to be complete within 1 year

    Measured by the Short Form (SF36) questionnaire

  8. Patient-reported dietary intake

    Time frame: Through study completion, expected to be complete within 1 year

    measured by food frequency questionnaire and 4-day food diary

  9. Patient-reported background and dietary habits

    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

  10. Patient-reported disability

    Time frame: During trial, expected to be complete within 1 year

    Health Assessment Questionnaire, disability index (HAQ)

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Sahlgrenska University Hospital

Registry information

Acronym: PIRA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 29, 2020
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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