Postprandial Inflammation in Rheumatoid Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-11-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Arthritis, Rheumatoid Inflammatory Response Dietary Exposure Diet, Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors

All data will be given a new code Before statistical analysis to mask treatment (study meal or Control) to the outcome assessor

Study Groups

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Meat

Patients with RA served a meal of meat

Group Type ACTIVE_COMPARATOR

Meal based on red meat, fish products or vegan products

Intervention Type OTHER

Three meals will be served

Meal based on red meat

Intervention Type OTHER

Matched Controls will be served only one meal of meat to compare response between (non-RA) matched controls and patients with RA

Fish

Patients with RA served a meal of fish

Group Type ACTIVE_COMPARATOR

Meal based on red meat, fish products or vegan products

Intervention Type OTHER

Three meals will be served

Vegan

Patients with RA served a vegan meal

Group Type ACTIVE_COMPARATOR

Meal based on red meat, fish products or vegan products

Intervention Type OTHER

Three meals will be served

Meat controls

Matched controls served a meal of meat

Group Type ACTIVE_COMPARATOR

Meal based on red meat

Intervention Type OTHER

Matched Controls will be served only one meal of meat to compare response between (non-RA) matched controls and patients with RA

Interventions

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Meal based on red meat, fish products or vegan products

Three meals will be served

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes