About this trial
The goal of this clinical trial is to reduce inflammation and improve glycemic control in healthy volunteers, parents, as well as children, adolescents and adults with or without diabetes. The main questions it aims to answer are: • does a reduction wheat gluten improve glycemic control and/or inflammatory biomarkers • does a reduction in certain amino acids (which is most common in wheat gluten) improve glycemic control and/or inflammatory biomarkers • can we identify individuals with an inflammatory response, which leads to poor glycemic control. Participants will eat gluten-free products as well as similar products containing gluten. They will also eat gluten together with probiotics to see if an effect of gluten can be reduced. Researchers will compare everyone with themselves (cross-over design) and if possible individuals with and without diabetes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Crossover
Treatments tested in this trial
gluten-free
Dietary supplementsee info in arm description
probiotic
Dietary supplementsee info in arm description
gluten
Dietary supplementsee info in arm description
Treatment groups
Trial outcomes
Primary outcomes
Stabilizing of blood sugar levels
Continuous glucose monitoring (CGM) data will be analysed together with activity level data, lower glucose peaks after a meal, adjusted for activity level.
Amino acid metabolism
Lowering of the aminoacid proline
Secondary outcomes
Blood Lipids
LDL, improved apolipoprotein B (APOB)
Glutathione S Transferases
Relative Glutathione S Transferases expression levels
Fibrinogen
Relative Fibrinogen expression levels
Other outcomes
multiomics explorative analyses
Genomics, transcriptomics2, metabolomics and proteomics analyses are planned
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Göteborg University
Lead sponsor
University of Skövde
Collaborator
Sahlgrenska University Hospital
Collaborator
Ekhaga foundation
Collaborator