Effect of Acute and Sub-acute Administration of Gluten on Extra-intestinal and Gastrointestinal Symptoms in Healthy Subjects

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Study arms

• Active comparator
  Gluten

  Patients receive 16 g of gluten acutely and afterwards 2 glutenfree muffins with 8 g of gluten for 5 days sub-acutely

  Other: Gluten

• Placebo comparator
  Placebo

  Patients receive 16 g of whey protein acutely and afterwards 2 glutenfree muffins for 5 days sub-acutely

  Other: Placebo

Interventions

• OtherGluten

  Tereos

• OtherPlacebo

  Whey protein from Nestlé Healthy Science

Primary outcomes

1. 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.

   Time frame: 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)

2. 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.

   Time frame: 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 outcomes

1. 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).

   Time frame: 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)

2. 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

   Time frame: 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)

3. 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.

   Time frame: During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41)

4. 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.

   Time frame: During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41)

5. 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.

   Time frame: During test visit 0 (day 0), test visit 2 (at day 21), after test visit 4 (at day 41)

6. 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.

   Time frame: 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

7. 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.

   Time frame: 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)