Gfree - For Improved Blood Sugar and Reduced Inflammation.

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.

Conditions

• Diabetes
• Celiac Disease
• Autoimmunity
• Metabolic Disease

Interventions

DIETARY_SUPPLEMENT

gluten-free

see info in arm description

DIETARY_SUPPLEMENT

probiotic

see info in arm description

DIETARY_SUPPLEMENT

gluten

see info in arm description

Sponsors & Collaborators

• University of Skövde

  collaborator OTHER

• Sahlgrenska University Hospital

  collaborator OTHER

• Ekhaga foundation

  collaborator UNKNOWN

• Göteborg University

  lead OTHER

Principal Investigators

• Åsa Torinsson Naluai, PhD · Göteborg University

• Katarina Ejeskär, PhD · University of Skövde

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

6 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-05-04

Primary Completion

2025-12-01

Completion

2030-12-31

Countries

• Sweden

Study Locations