Postprandial Inflammation in Rheumatoid Arthritis (PIRA)

March 24, 2025 updated by: Göteborg University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Circulating interleukin 6
Time Frame: From baseline up to 5 hours postprandial
Changes from fasting to postprandial
From baseline up to 5 hours postprandial
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
From baseline up to 5 hours postprandial
Circulating triacylglycerides
Time Frame: From baseline up to 5 hours postprandial
Blood lipid levels, Area Under curve from fasting to 5 hours postprandial
From baseline up to 5 hours postprandial
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
From baseline up to 5 hours postprandial
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
From baseline up to 5 hours postprandial
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
From baseline up to 5 hours postprandial

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: Measured at inclusion of trial, expected to be complete within 6 months
Measured by dual energy X-ray technology
Measured at inclusion of trial, expected to be complete within 6 months
Body composition
Time Frame: Measured at inclusion and during trial, expected to be complete within 1 year
measured by electric impedance analysis
Measured at inclusion and during trial, expected to be complete within 1 year
Resting metabolic rate
Time Frame: through study completion, expected within 1 year
measured by indirect calorimetry
through study completion, expected within 1 year
Glucose
Time Frame: From baseline up to 5 hours postprandial
blood glucose levels measured by NMR-analysis
From baseline up to 5 hours postprandial
Insulin
Time Frame: From baseline up to 5 hours postprandial
blood insulin levels measured by NMR-analysis
From baseline up to 5 hours postprandial
Patient-reported quality of life
Time Frame: through study completion, expected to be complete within 1 year
Measured by EQ5D-5L questionnaire
through study completion, expected to be complete within 1 year
Patient-reported health
Time Frame: through study completion, expected to be complete within 1 year
Measured by the Short Form (SF36) questionnaire
through study completion, expected to be complete within 1 year
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
Through study completion, expected to be complete within 1 year
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
During trial, expected to be complete within 1 year
Patient-reported disability
Time Frame: During trial, expected to be complete within 1 year
Health Assessment Questionnaire, disability index (HAQ)
During trial, expected to be complete within 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Göteborg University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sahlgrenska University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Helen HL Lindqvist, PhD, Göteborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 17, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 17, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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