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

NCT03798262 | Completed

• 1 other identifier: S58915
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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).

Conditions

Healthy Volunteers, Gluten

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Gluten

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Gluten OTHER

Tereos

Gluten

Placebo OTHER

Whey protein from Nestlé Healthy Science

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body Mass Index (BMI) of 20 - 25 kg/m2
• Stable body weight for at least 3 months prior to the start of the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (2)

Jan Tack

Leuven, 3000, Belgium

Location

TARGID

Leuven, 3000, Belgium

Location

Related Publications (1)

• Iven J, Geeraerts A, Vanuytsel T, Tack J, Van Oudenhove L, Biesiekierski JR. Impact of Acute and Sub-Acute Gluten Exposure on Gastrointestinal Symptoms and Psychological Responses in Non-Coeliac Gluten Sensitivity: A Randomised Crossover Study. United European Gastroenterol J. 2025 Sep;13(7):1295-1306. doi: 10.1002/ueg2.70014. Epub 2025 Mar 26.

  PMID: 40138597 DERIVED

MeSH Terms

Interventions

Glutens

Intervention Hierarchy (Ancestors)

Prolamins; Grain Proteins; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Seed Storage Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: single-blinded, randomised controlled, cross-over study

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: January 9, 2019
• Study Start: February 16, 2017
• Primary Completion: April 2, 2018
• Study Completion: April 2, 2018
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

BE (2)