Status:
COMPLETED
Effect of Acute and Sub-acute Administration of Gluten on Extra-intestinal and Gastrointestinal Symptoms in Healthy Subjects
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Healthy Volunteers, Gluten
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The investigators will investigate the effects of acute and sub-acute administration of gluten on mood, intestinal permeability, gastrointestinal symptoms and gut peptide levels in healthy volunteers ...
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) of 20 - 25 kg/m2
- Stable body weight for at least 3 months prior to the start of the study
Exclusion
- Medical
- Coeliac disease (excluded either by absence of the HLA-DQ2 and HLA-DQ8 haplotype or by a normal duodenal biopsy (Marsh 0) performed at endoscopy while on a gluten containing diet in individuals expressing the HLA-DQ2 (human leukocyte antigen) or HLA-DQ8 haplotype)
- Abdominal or thoracic surgery. Exception: appendectomy
- Gastrointestinal, endocrine or neurological diseases
- Cardiovascular, respiratory, renal or urinary diseases
- Hypertension
- Diagnosed food or drug allergies
- Psychiatric disorders
- Eating disorders
- Depressive disorders
- Anxiety disorders
- Psychotic disorders
- Restraint or emotional eating
- Dieters, especially no gluten-free diet or a diet low on gluten
- Medication on a regular basis, exception: oral contraception
- Smoking
- History of cannabis use or any other drug of abuse for at least 12 months prior to the study
- Alcohol abuse (more than 21 units of alcohol for men, more than 14 units for woman per week)
- Pregnant or breastfeeding women
Key Trial Info
Start Date :
February 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03798262
Start Date
February 16 2017
End Date
April 2 2018
Last Update
January 9 2019
Active Locations (2)
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1
Jan Tack
Leuven, Belgium, 3000
2
TARGID
Leuven, Belgium, 3000