PIRA: Postprandial Inflammation in Rheumatoid Arthritis

Sponsor

Göteborg University (Other)

Overall Status

Completed

CT.gov ID

NCT04247009

Collaborator

Sahlgrenska University Hospital, Sweden (Other)

Enrollment

Location

Arms

21.5

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

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.

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	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

56 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 :

Feb 1, 2020

Actual Primary Completion Date :

Nov 17, 2021

Actual Study Completion Date :

Nov 17, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Body composition [Measured at inclusion of trial, expected to be complete within 6 months]
Measured by dual energy X-ray technology
Body composition [Measured at inclusion and during trial, expected to be complete within 1 year]
measured by electric impedance analysis
Resting metabolic rate [through study completion, expected within 1 year]
measured by indirect calorimetry
Glucose [From baseline up to 5 hours postprandial]
blood glucose levels measured by NMR-analysis
Insulin [From baseline up to 5 hours postprandial]
blood insulin levels measured by NMR-analysis
Patient-reported quality of life [through study completion, expected to be complete within 1 year]
Measured by EQ5D-5L questionnaire
Patient-reported health [through study completion, expected to be complete within 1 year]
Measured by the Short Form (SF36) questionnaire
Patient-reported dietary intake [Through study completion, expected to be complete within 1 year]
measured by food frequency questionnaire and 4-day food diary
Patient-reported background and dietary habits [During trial, expected to be complete within 1 year]
Measured by questionnaire about socioeconomic status and changes in dietary habits related to perceived health
Patient-reported disability [During trial, expected to be complete within 1 year]
Health Assessment Questionnaire, disability index (HAQ)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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