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

Universitaire Ziekenhuizen KU Leuven20 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Healthy Volunteers, Gluten

Interventions

GlutenOTHER

Tereos

PlaceboOTHER

Whey protein from Nestlé Healthy Science

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Jan Tack

Leuven, Belgium

TARGID

Leuven, Belgium

Outcomes

Primary Outcomes

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)

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

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)

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)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.