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)
