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
| Type | Name | Description |
|---|---|---|
| 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 |
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.