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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05894746
Other study ID # GFREE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 4, 2023
Est. completion date December 1, 2030

Study information

Verified date June 2023
Source Göteborg University
Contact Åsa Torinsson Naluai, PhD
Phone +46768979149
Email asa.torinsson.naluai@gu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 1, 2030
Est. primary completion date December 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years and older
Eligibility Inclusion Criteria: - none Exclusion Criteria: - A diagnosis of celiac disease

Study Design


Intervention

Dietary Supplement:
gluten-free
see info in arm description
probiotic
see info in arm description
gluten
see info in arm description

Locations

Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg
Sweden University of Skövde Skövde

Sponsors (4)

Lead Sponsor Collaborator
Göteborg University Ekhaga foundation, Sahlgrenska University Hospital, Sweden, University of Skövde

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Other multiomics explorative analyses Genomics, transcriptomics2, metabolomics and proteomics analyses are planned 0 days to 4 weeks
Primary 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. 0 days to 4 weeks
Primary Amino acid metabolism Lowering of the aminoacid proline 0 days to 4 weeks
Secondary Blood Lipids LDL, improved apolipoprotein B (APOB) 0 days to 4 weeks
Secondary Glutathione S Transferases Relative Glutathione S Transferases expression levels 0 days to 4 weeks
Secondary Fibrinogen Relative Fibrinogen expression levels 0 days to 4 weeks
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