Gfree - For Improved Blood Sugar and Reduced Inflammation.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6+
SponsorGöteborg University

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • gluten-free

    Dietary supplement

    see info in arm description

  • probiotic

    Dietary supplement

    see info in arm description

  • gluten

    Dietary supplement

    see info in arm description

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: gluten-freeExperimental treatment 1 intervention
Group B: glutenActive comparator 2 interventions
Group C: probioticActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
0 days to 4 weeks
2

Amino acid metabolism

Lowering of the aminoacid proline

Time frame
0 days to 4 weeks

Secondary outcomes

1

Blood Lipids

LDL, improved apolipoprotein B (APOB)

Time frame
0 days to 4 weeks
2

Glutathione S Transferases

Relative Glutathione S Transferases expression levels

Time frame
0 days to 4 weeks
3

Fibrinogen

Relative Fibrinogen expression levels

Time frame
0 days to 4 weeks

Other outcomes

1

multiomics explorative analyses

Genomics, transcriptomics2, metabolomics and proteomics analyses are planned

Time frame
0 days to 4 weeks

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