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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 (HV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gluten | Active Comparator | Patients receive 16 g of gluten acutely and afterwards 2 glutenfree muffins with 8 g of gluten for 5 days sub-acutely |
|
| Placebo | Placebo Comparator | Patients receive 16 g of whey protein acutely and afterwards 2 glutenfree muffins for 5 days sub-acutely |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gluten | Other | Tereos |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of gluten acutely and sub-acutely on extraintestinal symptoms in HV measured on the Positive and Negative Affect Schedule | Change from baseline. Scores can be 'very slightly or not at all', 'a little', 'moderately', 'quite a bit', 'extremely'. Measured at day 0, day 15, day 20, day 36 and day 41. | At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 36), after test visit 4 (at day 41) |
| The effect of gluten acutely and sub-acutely on extraintestinal symptoms in HV measured on the Profile of Mood State. | Change from baseline. Scores are measured on the Visual Analogue Scale. The scale is ranged 0 - 10, in which 0 no occurrence of the symptom and 10 a lot occurrence of the symptom. Measured at day 0, day 15, day 20, day 36 and day 41. | At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 21), after test visit 3 (at day 36), after test visit 4 (at day 41) |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of gluten acutely and sub-acutely on gastrointestinal symptoms in HV measured on the visual analogue scale for gastrointestinal symptoms | Scores are measured on the Visual Analogue Scale. With '0' no complaints and '10' a lot of complaints (change from baseline). | At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 21), after test visit 3 (at day 36), after test visit 4 (at day 41) |
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Inclusion Criteria:
Exclusion Criteria:
Medical
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jan Tack | Leuven | 3000 | Belgium | |||
| TARGID |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40138597 | Derived | Iven J, Geeraerts A, Vanuytsel T, Tack J, Van Oudenhove L, Biesiekierski JR. Impact of Acute and Sub-Acute Gluten Exposure on Gastrointestinal Symptoms and Psychological Responses in Non-Coeliac Gluten Sensitivity: A Randomised Crossover Study. United European Gastroenterol J. 2025 Sep;13(7):1295-1306. doi: 10.1002/ueg2.70014. Epub 2025 Mar 26. |
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| ID | Term |
|---|---|
| D005983 | Glutens |
| ID | Term |
|---|---|
| D055315 | Prolamins |
| D000078522 | Grain Proteins |
| D010940 | Plant Proteins |
| D011506 | Proteins |
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single-blinded, randomised controlled, cross-over study
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| Other |
Whey protein from Nestlé Healthy Science |
|
| The effect of gluten acutely and sub-acutely on intestinal permeability (using the lactulose mannitol ratio) | Investigate change in intestinal permeability after gluten administration. In the urine we can measure the ratio lactulose/mannitol. This can be measured using High Performance Liquid Chromatography | At the beginning of test visit 0 (day 0), visit 1 (at day 15), test visit 2 (at day 20), after test visit 3 (at day 36), after test visit 4 (at day 41) |
| Effect of acute and sub-acute gluten administration on high sensitive reactive protein levels in blood samples | Change in high sensitive reactive protein levels measured at day 0, day 21 and day 41. | During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) |
| Effect of acute and sub-acute gluten administration on Lipopolysaccharide-Binding Protein levels in blood samples | Change in lipopolysaccharide-binding protein levels measured at day 0, day 21 and day 41. | During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) |
| Effect of acute and sub-acute gluten administration on Lipopolysaccharide levels in blood samples | Change in lipopolysaccharide levels measured at day 0, day 21 and day 41. | During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) |
| Effect of acute and sub-acute gluten administration on gut microbiota composition (stool samples) | Change in gut microbiota composition (compared to day 0) with focus on: Bifidobacterium, Lactobacillus, Enterobacteriaceae, E. coli; measured in stool samples. Analyses will provide an overall view of the gut microbiota composition. | After test visit 0 (day 0), day 13 and day 14, after test visit 1 (day 15), day 16, 17, 18, 19 and 20, two days before test visit 3 (day 34 and 35), day 36, 37, 38, 39, 40 |
| Effect of acute and sub-acute gluten administration on cortisol awakening response (saliva samples) | Change in cortisol levels between gluten and placebo administration (saliva samples). Measured using an ELISA assay. | Day before test visit 1 (day 14), test visit 1 (day 15), test visit 2 (day 21), day before test visit 3 (day 35), test visit 3 (day 36) and test visit 4 (day 41) |
| Leuven |
| 3000 |
| Belgium |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D055314 | Seed Storage Proteins |