Effect of Acute and Sub-acute Administration of Gluten on Extra-intestinal and Gastrointestinal Symptoms in Healthy Subjects
- Conditions
- Healthy Volunteers, Gluten
- Interventions
- Other: GlutenOther: Placebo
- Registration Number
- NCT03798262
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- 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 (HV).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Body Mass Index (BMI) of 20 - 25 kg/m2
- Stable body weight for at least 3 months prior to the start of the study
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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
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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)
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Pregnant or breastfeeding women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Gluten Gluten Patients receive 16 g of gluten acutely and afterwards 2 glutenfree muffins with 8 g of gluten for 5 days sub-acutely Placebo Placebo Patients receive 16 g of whey protein acutely and afterwards 2 glutenfree muffins for 5 days sub-acutely
- Primary Outcome Measures
Name Time Method The effect of gluten acutely and sub-acutely on extraintestinal symptoms in HV measured on the Positive and Negative Affect Schedule 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) 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.
The effect of gluten acutely and sub-acutely on extraintestinal symptoms in HV measured on the Profile of Mood State. 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) 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.
- Secondary Outcome Measures
Name Time Method The effect of gluten acutely and sub-acutely on intestinal permeability (using the lactulose mannitol ratio) 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) 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
Effect of acute and sub-acute gluten administration on gut microbiota composition (stool samples) 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 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.
The effect of gluten acutely and sub-acutely on gastrointestinal symptoms in HV measured on the visual analogue scale for gastrointestinal symptoms 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) Scores are measured on the Visual Analogue Scale. With '0' no complaints and '10' a lot of complaints (change from baseline).
Effect of acute and sub-acute gluten administration on high sensitive reactive protein levels in blood samples During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) Change in high sensitive reactive protein levels measured at day 0, day 21 and day 41.
Effect of acute and sub-acute gluten administration on Lipopolysaccharide-Binding Protein levels in blood samples During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) Change in lipopolysaccharide-binding protein levels measured at day 0, day 21 and day 41.
Effect of acute and sub-acute gluten administration on Lipopolysaccharide levels in blood samples During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41) Change in lipopolysaccharide levels measured at day 0, day 21 and day 41.
Effect of acute and sub-acute gluten administration on cortisol awakening response (saliva samples) 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) Change in cortisol levels between gluten and placebo administration (saliva samples). Measured using an ELISA assay.
Trial Locations
- Locations (2)
TARGID
🇧🇪Leuven, Belgium
Jan Tack
🇧🇪Leuven, Belgium