Postprandial Inflammation in Rheumatoid Arthritis (PIRA)

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.

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid; Inflammatory Response; Diet, Healthy; Dietary Exposure
• Intervention / Treatment: Other: Meal based on red meat, fish products or vegan products; Other: Meal based on red meat

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Not In US/Canada
    • Göteborg, Not In US/Canada, Sweden, 405 30
      • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Meat; Patients with RA served a meal of meat	Other: Meal based on red meat, fish products or vegan products; Three meals will be served; Other: Meal 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
Active Comparator: Fish; Patients with RA served a meal of fish	Other: Meal based on red meat, fish products or vegan products; Three meals will be served
Active Comparator: Vegan; Patients with RA served a vegan meal	Other: Meal based on red meat, fish products or vegan products; Three meals will be served
Active Comparator: Meat controls; Matched controls served a meal of meat	Other: Meal 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating interleukin 6	Changes from fasting to postprandial	From baseline up to 5 hours postprandial
Circulating high sensitive C-reactive protein (CRP)	Changes from fasting to 5 hours postprandial, area under curve	From baseline up to 5 hours postprandial
Circulating triacylglycerides	Blood lipid levels, Area Under curve from fasting to 5 hours postprandial	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	From baseline up to 5 hours postprandial
Serum metabolomics	Patterns of nuclear magnetic resonance (NMR) analysis of metabolites, analysis of several timepoints separately	From baseline up to 5 hours postprandial
Urine metabolomics	Patterns of nuclear magnetic resonance (NMR) analysis of metabolites,analysis of several timepoints separately	From baseline up to 5 hours postprandial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Measured by dual energy X-ray technology	Measured at inclusion of trial, expected to be complete within 6 months
Body composition	measured by electric impedance analysis	Measured at inclusion and during trial, expected to be complete within 1 year
Resting metabolic rate	measured by indirect calorimetry	through study completion, expected within 1 year
Glucose	blood glucose levels measured by NMR-analysis	From baseline up to 5 hours postprandial
Insulin	blood insulin levels measured by NMR-analysis	From baseline up to 5 hours postprandial
Patient-reported quality of life	Measured by EQ5D-5L questionnaire	through study completion, expected to be complete within 1 year
Patient-reported health	Measured by the Short Form (SF36) questionnaire	through study completion, expected to be complete within 1 year
Patient-reported dietary intake	measured by food frequency questionnaire and 4-day food diary	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	During trial, expected to be complete within 1 year
Patient-reported disability	Health Assessment Questionnaire, disability index (HAQ)	During trial, expected to be complete within 1 year

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Sahlgrenska University Hospital, Sweden
• Investigators: Principal Investigator: Helen HL Lindqvist, PhD, Göteborg University

Publications and helpful links

General Publications

• Lindqvist HM, Wallengren O, Eriksson A, Hulander E, Winkvist A, Bärebring L. Validity of bioimpedance for assessment of fat-free mass in women with Rheumatoid Arthritis compared to non-rheumatic controls. Clin Nutr ESPEN. 2022 Feb;47:333-338. doi: 10.1016/j.clnesp.2021.11.016. Epub 2021 Nov 14.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): November 17, 2021
• Study Completion (Actual): November 17, 2021

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): December 2, 2021
• Last Update Submitted That Met QC Criteria: December 1, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: rheumatoid arthritis; inflammation; postprandial; diet; RA; PIRA
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Inflammation
• Other Study ID Numbers: PIRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data cannot be shared publicly because of Swedish law. The datasets analysed could be made available from the corresponding author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No