Healthy Volunteers, Gluten Clinical Trial
Official title:
Effect of Acute and Sub-acute Administration of Gluten on Extra-intestinal and Gastrointestinal Symptoms in Healthy Subjects
| NCT number | NCT03798262 |
| Other study ID # | S58915 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | February 16, 2017 |
| Est. completion date | April 2, 2018 |
| Verified date | January 2019 |
| Source | Universitaire Ziekenhuizen Leuven |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | April 2, 2018 |
| Est. primary completion date | April 2, 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Jan Tack | Leuven | |
| Belgium | TARGID | Leuven |
| Lead Sponsor | Collaborator |
|---|---|
| Universitaire Ziekenhuizen Leuven |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | |
| Primary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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 | |
| Secondary | 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) |