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Postprandial Inflammation in Rheumatoid Arthritis (PIRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04247009
Recruitment Status : Suspended (Due to risk for covid-19 spreading, the study was suspended 12 march 2020.)
First Posted : January 29, 2020
Last Update Posted : May 21, 2020
Sponsor:
Collaborator:
Sahlgrenska University Hospital, Sweden
Information provided by (Responsible Party):
Göteborg University

Brief 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.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Inflammatory Response Dietary Exposure Diet, Healthy Other: Meal based on red meat, fish products or vegan products Other: Meal based on red meat Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Masking Description: All data will be given a new code Before statistical analysis to mask treatment (study meal or Control) to the outcome assessor
Primary Purpose: Basic Science
Official Title: Postprandial Inflammation in Rheumatoid Arthritis
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04247009


Locations
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Sweden
Sahlgrenska University Hospital
Göteborg, Not In US/Canada, Sweden, 405 30
Sponsors and Collaborators
Göteborg University
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Helen HL Lindqvist, PhD Göteborg University
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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT04247009    
Other Study ID Numbers: PIRA
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Göteborg University:
postprandial
inflammation
rheumatoid arthritis
RA
diet
PIRA
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Inflammation
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes