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Trials / Completed

CompletedNCT04247009

Postprandial Inflammation in Rheumatoid Arthritis

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
56 (actual)
Sponsor
Göteborg University · Academic / Other
Sex
Female
Age
20 Years – 70 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERMeal based on red meat, fish products or vegan productsThree meals will be served
OTHERMeal based on red meatMatched Controls will be served only one meal of meat to compare response between (non-RA) matched controls and patients with RA

Timeline

Start date
2020-02-01
Primary completion
2021-11-17
Completion
2021-11-17
First posted
2020-01-29
Last updated
2025-03-26

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT04247009. Inclusion in this directory is not an endorsement.

Postprandial Inflammation in Rheumatoid Arthritis (NCT04247009) · Clinical Trials Directory