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

What this Trial Is About

Researchers are investigating whether reducing wheat gluten or certain amino acids commonly found in wheat gluten can improve blood sugar control and reduce inflammation in healthy volunteers, parents, children, adolescents, and adults, including those with diabetes. The study also seeks to identify individuals who have an inflammatory response leading to poor blood sugar control. It explores the connections between diabetes, inflammation, and severe COVID-19 infection. Participants will follow a diet with four different phases over four weeks their usual diet, a gluten-free diet, a diet containing wheat gluten, and a diet including gluten combined with probiotics. During these periods, participants will consume gluten-free or regular gluten-containing pasta meals and take probiotics as described. The study uses a crossover design where each participant serves as their own control. Continuous glucose monitors and activity trackers will be used to assess glucose uptake during the study. Participants will attend four clinical visits at baseline and weekly intervals for blood sampling. They will also collect samples at home, including capillary blood, feces, urine, buccal swabs, and saliva, and complete questionnaires about diet, diabetes risk factors, and COVID-19. The main outcomes include stabilizing blood sugar levels and amino acid metabolism. Secondary outcomes include blood lipids, glutathione S transferases, and fibrinogen. Total study duration for each participant is four weeks.

Gfree - For Improved Blood Sugar and Reduced Inflammation.