Clinical trial NCT04247009: Postprandial Inflammation in Rheumatoid Arthritis
Official title: Postprandial Inflammation in Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis, Rheumatoid
Inflammatory Response
Dietary Exposure
Diet, Healthy
Keywords: postprandial
inflammation
rheumatoid arthritis
RA
diet
PIRA
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
First posted: 2020-01-29
Enrollment: 56
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Circulating interleukin 6
timeFrame: From baseline up to 5 hours postprandial
measure: Circulating high sensitive C-reactive protein (CRP)
timeFrame: From baseline up to 5 hours postprandial
measure: Circulating triacylglycerides
timeFrame: From baseline up to 5 hours postprandial
measure: Gene expression analysis
timeFrame: From baseline up to 5 hours postprandial
measure: Serum metabolomics
timeFrame: From baseline up to 5 hours postprandial
measure: Urine metabolomics
timeFrame: From baseline up to 5 hours postprandial
Secondary outcomes:
measure: Body composition
timeFrame: Measured at inclusion of trial, expected to be complete within 6 months
measure: Body composition
timeFrame: Measured at inclusion and during trial, expected to be complete within 1 year
measure: Resting metabolic rate
timeFrame: through study completion, expected within 1 year
measure: Glucose
timeFrame: From baseline up to 5 hours postprandial
measure: Insulin
timeFrame: From baseline up to 5 hours postprandial
measure: Patient-reported quality of life
timeFrame: through study completion, expected to be complete within 1 year
measure: Patient-reported health
timeFrame: through study completion, expected to be complete within 1 year
measure: Patient-reported dietary intake
timeFrame: Through study completion, expected to be complete within 1 year
measure: Patient-reported background and dietary habits
timeFrame: During trial, expected to be complete within 1 year
measure: Patient-reported disability
timeFrame: During trial, expected to be complete within 1 year
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
state: Not In US/Canada
Study officials:
affiliation: Göteborg University
name: Helen HL Lindqvist, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.