In vivo effects of amylase trypsin inhibitors from wheat in the human gut: proof of cause of non-coeliac wheat sensitivity in irritable bowel syndrome?

• Conditions: Non-coeliac wheat sensitivity; wheat sensitivity; 10018012

• Registration Number: NL-OMON52091
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

1) No gastrointestinal complaints and/or disease
2) Age between 18-65 years
3) BMI between 20-30 kg/m2

Exclusion Criteria

1) History of severe cardiovascular, respiratory, urogenital,
gastrointestinal/hepatic, hematological/immunologic, HEENT (head, ears, eyes,
nose, throat), dermatological/connective tissue, musculoskeletal,
metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy,
major surgery and/or laboratory assessments which might limit participation in
or completion of the study protocol.
2) Use of medication, including nutritional supplements, except oral
contraceptives, within 14 days prior to testing.
3) Administration of investigational drugs or participation in any scientific
intervention study, which may interfere with this study (to be decided by the
principal investigator), in the 180 days prior to the study.
4) Major abdominal surgery interfering with gastrointestinal function.
5) Pregnancy, lactation.
6) Excessive alcohol consumption, smoking, drug use.
7) Blood donation within 3 months before or after the study period.
8) Plan to lose weight or follow a specific diet within the study period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Intestinal barrier function associated gene expression induced by ATIs. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Intestinal barrier function associated protein levels and blood markers<br /><br>Markers of immune activation: gene expression, tissue infiltration of immune<br /><br>cells, quantification immune cell populations and blood markers </p><br>