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| Name | Class |
|---|---|
| Sahlgrenska University Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meat | Active Comparator | Patients with RA served a meal of meat |
|
| Fish | Active Comparator | Patients with RA served a meal of fish |
|
| Vegan | Active Comparator | Patients with RA served a vegan meal |
|
| Meat controls | Active Comparator | Matched controls served a meal of meat |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meal based on red meat, fish products or vegan products | Other | Three meals will be served |
|
| 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 |
| 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 |
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Inclusion Criteria for patients with RA:
Inclusion Criteria for healthy controls:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen HL Lindqvist, PhD | Göteborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | Not in US/Canada | 405 30 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40418340 | Derived | 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. | |
| 40217385 | Derived |
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Data cannot be shared publicly because of Swedish law. The datasets analysed could be made available from the corresponding author on reasonable request.
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D005396 | Fish Products |
| ID | Term |
|---|---|
| D017747 | Seafood |
| D008460 | Meat |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 |
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All data will be given a new code Before statistical analysis to mask treatment (study meal or Control) to the outcome assessor
| 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 |
|
| 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 |
| 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. |
| 37814020 | Derived | 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. |
| 35063223 | Derived | 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. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Physiological Phenomena |
| D019602 | Food and Beverages |