Clinical Trial

Gfree - For Improved Blood Sugar and Reduced Inflammation.

Recruiting
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Record status
This record was last updated October 15, 2024 (before its estimated December 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-06-07.
Trial Details
NCT Number NCT05894746
Lead Sponsor Göteborg University
Collaborators: University of Skövde, Sahlgrenska University Hospital, Ekhaga foundation
Conditions Diabetes, Celiac Disease, Autoimmunity, Metabolic Disease
Enrollment 60 participants
Start Date 2023-05-04
Primary Completion 2025-12-01 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-10-15