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Postprandial Inflammation in Rheumatoid Arthritis (PIRA)

Primary Purpose

Arthritis, Rheumatoid, Inflammatory Response, Dietary Exposure

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Meal based on red meat, fish products or vegan products
Meal based on red meat
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Arthritis, Rheumatoid focused on measuring postprandial, inflammation, rheumatoid arthritis, RA, diet, PIRA

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Meat

Fish

Vegan

Meat controls

Arm Description

Patients with RA served a meal of meat

Patients with RA served a meal of fish

Patients with RA served a vegan meal

Matched controls served a meal of meat

Outcomes

Primary Outcome Measures

Circulating interleukin 6
Changes from fasting to postprandial
Circulating high sensitive C-reactive protein (CRP)
Changes from fasting to 5 hours postprandial, area under curve
Circulating triacylglycerides
Blood lipid levels, Area Under curve from fasting to 5 hours postprandial
Gene expression analysis
Changes in gene expressions related to inflammation and disease activity in peripheral blood mononuclear cells
Serum metabolomics
Patterns of nuclear magnetic resonance (NMR) analysis of metabolites, analysis of several timepoints separately
Urine metabolomics
Patterns of nuclear magnetic resonance (NMR) analysis of metabolites,analysis of several timepoints separately

Secondary Outcome Measures

Body composition
Measured by dual energy X-ray technology
Body composition
measured by electric impedance analysis
Resting metabolic rate
measured by indirect calorimetry
Glucose
blood glucose levels measured by NMR-analysis
Insulin
blood insulin levels measured by NMR-analysis
Patient-reported quality of life
Measured by EQ5D-5L questionnaire
Patient-reported health
Measured by the Short Form (SF36) questionnaire
Patient-reported dietary intake
measured by food frequency questionnaire and 4-day food diary
Patient-reported background and dietary habits
Measured by questionnaire about socioeconomic status and changes in dietary habits related to perceived health
Patient-reported disability
Health Assessment Questionnaire, disability index (HAQ)

Full Information

First Posted
January 21, 2020
Last Updated
December 1, 2021
Sponsor
Göteborg University
Collaborators
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT04247009
Brief Title
Postprandial Inflammation in Rheumatoid Arthritis
Acronym
PIRA
Official Title
Postprandial Inflammation in Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
November 17, 2021 (Actual)
Study Completion Date
November 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid, Inflammatory Response, Dietary Exposure, Diet, Healthy
Keywords
postprandial, inflammation, rheumatoid arthritis, RA, diet, PIRA

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
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
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Meat
Arm Type
Active Comparator
Arm Description
Patients with RA served a meal of meat
Arm Title
Fish
Arm Type
Active Comparator
Arm Description
Patients with RA served a meal of fish
Arm Title
Vegan
Arm Type
Active Comparator
Arm Description
Patients with RA served a vegan meal
Arm Title
Meat controls
Arm Type
Active Comparator
Arm Description
Matched controls served a meal of meat
Intervention Type
Other
Intervention Name(s)
Meal based on red meat, fish products or vegan products
Intervention Description
Three meals will be served
Intervention Type
Other
Intervention Name(s)
Meal based on red meat
Intervention Description
Matched Controls will be served only one meal of meat to compare response between (non-RA) matched controls and patients with RA
Primary Outcome Measure Information:
Title
Circulating interleukin 6
Description
Changes from fasting to postprandial
Time Frame
From baseline up to 5 hours postprandial
Title
Circulating high sensitive C-reactive protein (CRP)
Description
Changes from fasting to 5 hours postprandial, area under curve
Time Frame
From baseline up to 5 hours postprandial
Title
Circulating triacylglycerides
Description
Blood lipid levels, Area Under curve from fasting to 5 hours postprandial
Time Frame
From baseline up to 5 hours postprandial
Title
Gene expression analysis
Description
Changes in gene expressions related to inflammation and disease activity in peripheral blood mononuclear cells
Time Frame
From baseline up to 5 hours postprandial
Title
Serum metabolomics
Description
Patterns of nuclear magnetic resonance (NMR) analysis of metabolites, analysis of several timepoints separately
Time Frame
From baseline up to 5 hours postprandial
Title
Urine metabolomics
Description
Patterns of nuclear magnetic resonance (NMR) analysis of metabolites,analysis of several timepoints separately
Time Frame
From baseline up to 5 hours postprandial
Secondary Outcome Measure Information:
Title
Body composition
Description
Measured by dual energy X-ray technology
Time Frame
Measured at inclusion of trial, expected to be complete within 6 months
Title
Body composition
Description
measured by electric impedance analysis
Time Frame
Measured at inclusion and during trial, expected to be complete within 1 year
Title
Resting metabolic rate
Description
measured by indirect calorimetry
Time Frame
through study completion, expected within 1 year
Title
Glucose
Description
blood glucose levels measured by NMR-analysis
Time Frame
From baseline up to 5 hours postprandial
Title
Insulin
Description
blood insulin levels measured by NMR-analysis
Time Frame
From baseline up to 5 hours postprandial
Title
Patient-reported quality of life
Description
Measured by EQ5D-5L questionnaire
Time Frame
through study completion, expected to be complete within 1 year
Title
Patient-reported health
Description
Measured by the Short Form (SF36) questionnaire
Time Frame
through study completion, expected to be complete within 1 year
Title
Patient-reported dietary intake
Description
measured by food frequency questionnaire and 4-day food diary
Time Frame
Through study completion, expected to be complete within 1 year
Title
Patient-reported background and dietary habits
Description
Measured by questionnaire about socioeconomic status and changes in dietary habits related to perceived health
Time Frame
During trial, expected to be complete within 1 year
Title
Patient-reported disability
Description
Health Assessment Questionnaire, disability index (HAQ)
Time Frame
During trial, expected to be complete within 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen HL Lindqvist, PhD
Organizational Affiliation
Göteborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Göteborg
State/Province
Not In US/Canada
ZIP/Postal Code
405 30
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
35063223
Citation
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.
Results Reference
derived

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Postprandial Inflammation in Rheumatoid Arthritis

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