GFREE - A Study for Improved Blood Sugar Levels, Reduced Inflammation and for Increasing Knowledge of the Connection Between Diabetes and COVID-19.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Healthy Volunteers: t
View:

• \- none

Locations
Other Locations
Sweden
Sahlgrenska University Hospital
NOT_YET_RECRUITING
Gothenburg
University of Skövde
RECRUITING
Skövde
Contact Information
Primary
Åsa Torinsson Naluai, PhD
asa.torinsson.naluai@gu.se
(0046)768-979149
Backup
Katarina Ejeskär Ejeskär, PhD
Katarina.Ejeskar@his.se
Time Frame
Start Date: 2023-05-04
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 60
Treatments
Experimental: gluten-free
The study participants will start the gluten-free diet and be asked to exchange any products they normally buy with similar products. Three days in the week they will eat a meal with gluten free pasta. Two to six hours after the meal they will take samples at home and store until they return to the clinic.
Active_comparator: gluten
The study participants will continue the gluten-free diet and be asked to exchange any products they normally buy with similar products. Three days however, in the week they will eat a meal with regular gluten containing pasta. Two to six hours after the meal they will take samples at home and store until they return to the clinic.
Active_comparator: probiotic
The study participants will continue the gluten-free diet and be asked to exchange any products they normally buy with similar products. During the week they will also take probiotic (Probion, Active) every morning and every evening. Three days however, in the week they will eat a meal with regular gluten containing pasta. Two to six hours after the meal they will take samples at home and store until they return to the clinic.
Related Therapeutic Areas
Sponsors
Collaborators: University of Skövde, Ekhaga foundation, Sahlgrenska University Hospital
Leads: Göteborg University

This content was sourced from clinicaltrials.gov