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Arthritis, RheumatoidPIRANCT04247009

Postprandial Inflammation in Rheumatoid Arthritis

A study testing Meal based on red meat, fish products or vegan products and Meal based on red meat in people with Arthritis, Rheumatoid and Inflammatory Response, run by Göteborg University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 years, women onlyHealthy volunteers can take part
What is being tested?
Meal based on red meat, fish products or vegan products and Meal based on red meat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteSweden
Study dates
1 Feb 2020to 17 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
  • Absence of diagnosis of RA
  • BMI 18.5-30.0 kg/m2
  • Self-assessed as healthy

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Sahlgrenska University Hospital

    Gothenburg, Not in US/Canada, 405 30

Other trials in Sweden

About this study

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.

Read the 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.

Being tested
Meal based on red meat, fish products or vegan products, Meal based on red meat
Keywords
postprandial, inflammation, rheumatoid arthritis, RA, diet, PIRA
Medical subject headings
Arthritis, Rheumatoid, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meal based on red meat, fish products or vegan productsOther

    Three meals will be served

  • Meal based on red meatOther

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

Study groups in NCT04247009
Study groupRoleWhat they receive
MeatActive comparatorPatients with RA served a meal of meat
Receives: Other: Meal based on red meat, fish products or vegan products; Other: Meal based on red meat
FishActive comparatorPatients with RA served a meal of fish
Receives: Other: Meal based on red meat, fish products or vegan products
VeganActive comparatorPatients with RA served a vegan meal
Receives: Other: Meal based on red meat, fish products or vegan products
Meat controlsActive comparatorMatched controls served a meal of meat
Receives: Other: Meal based on red meat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Circulating interleukin 6

    Changes from fasting to postprandial

    Measured: From baseline up to 5 hours postprandial

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

    Changes from fasting to 5 hours postprandial, area under curve

    Measured: From baseline up to 5 hours postprandial

  3. Circulating triacylglycerides

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

    Measured: From baseline up to 5 hours postprandial

  4. Gene expression analysis

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

    Measured: From baseline up to 5 hours postprandial

  5. Serum metabolomics

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

    Measured: From baseline up to 5 hours postprandial

  6. Urine metabolomics

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

    Measured: From baseline up to 5 hours postprandial

Secondary outcomes (10)

  1. Body composition

    Measured by dual energy X-ray technology

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

  2. Body composition

    measured by electric impedance analysis

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

  3. Resting metabolic rate

    measured by indirect calorimetry

    Measured: through study completion, expected within 1 year

  4. Glucose

    blood glucose levels measured by NMR-analysis

    Measured: From baseline up to 5 hours postprandial

  5. Insulin

    blood insulin levels measured by NMR-analysis

    Measured: From baseline up to 5 hours postprandial

  6. Patient-reported quality of life

    Measured by EQ5D-5L questionnaire

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

  7. Patient-reported health

    Measured by the Short Form (SF36) questionnaire

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

  8. Patient-reported dietary intake

    measured by food frequency questionnaire and 4-day food diary

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

  9. Patient-reported background and dietary habits

    Measured by questionnaire about socioeconomic status and changes in dietary habits related to perceived health

    Measured: During trial, expected to be complete within 1 year

  10. Patient-reported disability

    Health Assessment Questionnaire, disability index (HAQ)

    Measured: During trial, expected to be complete within 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2020
  2. Study start1 Feb 2020
  3. Primary completion17 Nov 2021
  4. Study completion17 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04247009
Sponsor's protocol ID
PIRA
Acronym
PIRA
Status last verified
Mar 2025
First submitted
21 Jan 2020
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data cannot be shared publicly because of Swedish law. The datasets analysed could be made available from the corresponding author on reasonable request.

Publications

  • Lindqvist HM, Hulander E, Barebring L, Gjertsson I, Winkvist A. A randomized controlled cross-over trial of differences in acute effects on serum metabolites from isocaloric meals based on red meat, fatty fish, or soy protein. Eur J Nutr. 2025 May 26;64(5):187. doi: 10.1007/s00394-025-03710-0.

    PubMed 40418340

  • Sallstrom T, Barebring L, Hulander E, Gjertsson I, Winkvist A, Lindqvist HM. Inflammatory and lipemic response to red meat intake in women with and without Rheumatoid Arthritis: a single meal study within a randomized controlled trial. BMC Nutr. 2025 Apr 11;11(1):74. doi: 10.1186/s40795-025-01055-9.

    PubMed 40217385

  • Lindqvist HM, Gjertsson I, Hulander E, Barebring L, Winkvist A. Exploring the differences in serum metabolite profiles after intake of red meat in women with rheumatoid arthritis and a matched control group. Eur J Nutr. 2024 Feb;63(1):221-230. doi: 10.1007/s00394-023-03257-y. Epub 2023 Oct 9.

    PubMed 37814020

  • Lindqvist HM, Wallengren O, Eriksson A, Hulander E, Winkvist A, Barebring 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.

    PubMed 35063223

Questions about this trial

What is this clinical trial studying?

A study testing Meal based on red meat, fish products or vegan products and Meal based on red meat in people with Arthritis, Rheumatoid and Inflammatory Response, run by Göteborg University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Circulating interleukin 6 (time frame: From baseline up to 5 hours postprandial). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04247009, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.

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