Clinical trial NCT05894746: Gfree - For Improved Blood Sugar and Reduced Inflammation.
Official title: GFREE - A Study for Improved Blood Sugar Levels, Reduced Inflammation and for Increasing Knowledge of the Connection Between Diabetes and COVID-19.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes
Celiac Disease
Autoimmunity
Metabolic Disease
Keywords: gluten
probiotics
diet
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: University of Skövde
name: Sahlgrenska University Hospital
name: Ekhaga foundation
First posted: 2023-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Four week crossover trial with three arms, gluten-free, gluten and gluten with probiotic
Primary purpose: PREVENTION

Brief 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.

Detailed description: BACKGROUND AND PURPOSE Many diseases, which are common in high-income countries, have an inflammatory component. In the world's rich countries, about 10% of the population will be diagnosed with a traditional inflammatory autoimmune disease during their lifetime. In an autoimmune disease, the body produces auto-antibodies against the body's own protein and the immune system destroys the body's own tissues. There are hundreds of different types of autoimmune diseases where some of the most common are; celiac disease (gluten intolerance), psoriasis, type 1 diabetes (T1D), multiple sclerosis, rheumatic diseases or thyroid diseases. Diseases such as cardiovascular disease, type 2 diabetes (T2D) and Alzheimer's disease are now also considered to have inflammatory components, and so-called auto-antibodies have been identified that indicate autoimmunity also in these diseases. Autoantibodies have also been identified in COVID-19 patients.

To try to understand the biology behind autoimmunity and inflammatory disease, the investigators have analyzed the entire genome of patients with celiac disease as a model for autoimmunity. Celiac disease is a good so-called model disease for autoimmunity because the autoimmune reaction can be switched on and off with the help of gluten in the diet. With a strict gluten-free diet, virtually all signs of illness disappear and the inflammation ceases. The results from our whole genome analysis showed that genes involved in amino acid signaling were important for disease development and pointed to associations between celiac disease, T2D and anorexia. These results were somewhat surprising and the investigators began to look at the role of nutritional signaling and amino acids in inflammatory processes further.

The purpose of this study is to test whether a reduction in certain amino acids (which is most common in wheat gluten) can improve glycemic control in healthy volunteers, parents, as well as children, adolescents and adults with diabetes and whether levels of inflammatory amino acids may be one of the factors behind the link between diabetes and severe COVID-19 infection.

The participants will, for 4 weeks, eat one week as usual, eat one week wheat gluten-free, one week wheat gluten and one week with gluten and probiotics. The participants will be provided with continuous glucose monitors and activity-tracking bracelets. The investigators will analyze the efficiency of glucose uptake using continuous glucose monitors (CGM). During these four weeks, the research subjects will be admitted for 4 clinical visits (baseline, after 1 week, 2 weeks, 3 weeks) where blood samples will be taken. Also, during these weeks the participant will take capillary blood samples, faeces, urine, buccal swabs and saliva at home and fill out a questionnaire based on diet and risk factors for diabetes and questions about COVID-19.

Total number of participants: 60 Sampling occasions per participant: 15 Follow-up period per participant: 4 weeks Number of years for inclusion: 2 years (20221201-20241201)

Eligibility criteria: Inclusion Criteria:

- none

Exclusion Criteria:

- A diagnosis of celiac disease

Primary outcomes:
measure: Stabilizing of blood sugar levels
timeFrame: 0 days to 4 weeks
measure: Amino acid metabolism
timeFrame: 0 days to 4 weeks
Secondary outcomes:
measure: Blood Lipids
timeFrame: 0 days to 4 weeks
measure: Glutathione S Transferases
timeFrame: 0 days to 4 weeks
measure: Fibrinogen
timeFrame: 0 days to 4 weeks
Other outcomes:
measure: multiomics explorative analyses
timeFrame: 0 days to 4 weeks
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Skövde
country: Sweden
facility: University of Skövde
Study officials:
affiliation: Göteborg University
name: Åsa Torinsson Naluai, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Skövde
name: Katarina Ejeskär, PhD
role: STUDY_DIRECTOR
References: