As the most important staple food, wheat contributes significantly to our protein, vitamin, mineral and fibre intake. For consumers with coeliac disease and wheat allergy, non-celiac wheat sensitivity (NCWS) and irritable bowel syndrome (IBS) wheat consumption is problematic.
In in vitro studies amylase/trypsin inhibitors (ATIs) have been indicated to be important factors in symptom generation in NCWS and IBS.
They are known to have an enzyme inhibitory effect in the gut and are known to play a role in human immunogenic reactions (contact allergy, bakers asthma and likely also gastrointestinal immune reactions). The lack of scientific proof of their in vivo effect in humans, leaves room for speculation in social media and hinders proper nutritional advice to patients with NCWS and IBS, From an economic perspective the lack of proof limits the cereal food processing chain to increase food safety by appropriate raw material selection, proper mitigation measures during processing and for the further future, to breed cereals with improved impact on human health and concomitantly with improved agronomic properties (increased yields and biotic stress resistance and reduced crop losses). We propose here the first in vivo human study to establish a potential relationship of a well characterised ATI preparation with intestinal mucosal alterations and symptoms.

To this end we propose to isolate well defined and characerised ATIs from bread wheat and Einkorn wheat. We propose to perform a double-blind placebo-controlled trial in healthy volunteers and in patients suffering from non NCWS but otherwise healthy. In this trial subjects will receive either isolated gluten, containing also ATI’, or isolated pure ATI’s. Supply will either be by oral ingestion or by nasoduodenal infusion, A solution containing equivalent amounts of albumin protein, will serve as ATI free control. After supply, the effects on GI symptoms, Immune markers in duodenal biopsy material and presence and enzyme inhibitory activity of ATIs in duodenal fluid aspirates will be determined.