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Completed

NCT Number: NCT03798262

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

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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Key information

Conditions

Healthy Volunteers, Gluten

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jan Tack, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gluten

Other

Tereos

Placebo

Other

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

    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)

    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.

  2. The effect of gluten acutely and sub-acutely on extraintestinal symptoms in HV measured on the Profile of Mood State.

    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)

    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 outcomes

  1. The effect of gluten acutely and sub-acutely on gastrointestinal symptoms in HV measured on the visual analogue scale for gastrointestinal symptoms

    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)

    Scores are measured on the Visual Analogue Scale. With '0' no complaints and '10' a lot of complaints (change from baseline).

  2. The effect of gluten acutely and sub-acutely on intestinal permeability (using the lactulose mannitol ratio)

    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)

    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

  3. Effect of acute and sub-acute gluten administration on high sensitive reactive protein levels in blood samples

    Time frame: 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.

  4. Effect of acute and sub-acute gluten administration on Lipopolysaccharide-Binding Protein levels in blood samples

    Time frame: 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.

  5. Effect of acute and sub-acute gluten administration on Lipopolysaccharide levels in blood samples

    Time frame: 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.

  6. Effect of acute and sub-acute gluten administration on gut microbiota composition (stool samples)

    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

    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.

  7. Effect of acute and sub-acute gluten administration on cortisol awakening response (saliva samples)

    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)

    Change in cortisol levels between gluten and placebo administration (saliva samples). Measured using an ELISA assay.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 9, 2019
Registry last updated
Jan 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.