Postprandial Inflammation in Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

— PIRA  

Official title:

Postprandial Inflammation in Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04247009
• Other study ID #: PIRA
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: November 17, 2021

Study information

• Verified date: December 2021
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 17, 2021
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Diet, Healthy
• Dietary Exposure
• Inflammation
• Inflammatory Response

Intervention

Other:
• Meal based on red meat, fish products or vegan products
Three meals will be served
• 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

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Göteborg	Not In US/Canada

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating interleukin 6	Changes from fasting to postprandial	From baseline up to 5 hours postprandial
Primary	Circulating high sensitive C-reactive protein (CRP)	Changes from fasting to 5 hours postprandial, area under curve	From baseline up to 5 hours postprandial
Primary	Circulating triacylglycerides	Blood lipid levels, Area Under curve from fasting to 5 hours postprandial	From baseline up to 5 hours postprandial
Primary	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
Primary	Serum metabolomics	Patterns of nuclear magnetic resonance (NMR) analysis of metabolites, analysis of several timepoints separately	From baseline up to 5 hours postprandial
Primary	Urine metabolomics	Patterns of nuclear magnetic resonance (NMR) analysis of metabolites,analysis of several timepoints separately	From baseline up to 5 hours postprandial
Secondary	Body composition	Measured by dual energy X-ray technology	Measured at inclusion of trial, expected to be complete within 6 months
Secondary	Body composition	measured by electric impedance analysis	Measured at inclusion and during trial, expected to be complete within 1 year
Secondary	Resting metabolic rate	measured by indirect calorimetry	through study completion, expected within 1 year
Secondary	Glucose	blood glucose levels measured by NMR-analysis	From baseline up to 5 hours postprandial
Secondary	Insulin	blood insulin levels measured by NMR-analysis	From baseline up to 5 hours postprandial
Secondary	Patient-reported quality of life	Measured by EQ5D-5L questionnaire	through study completion, expected to be complete within 1 year
Secondary	Patient-reported health	Measured by the Short Form (SF36) questionnaire	through study completion, expected to be complete within 1 year
Secondary	Patient-reported dietary intake	measured by food frequency questionnaire and 4-day food diary	Through study completion, expected to be complete within 1 year
Secondary	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
Secondary	Patient-reported disability	Health Assessment Questionnaire, disability index (HAQ)	During trial, expected to be complete within 1 year