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Gluten and (Extra-)Intestinal Symptoms in NCGS

NCT05779358 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2023-03-22

No results posted yet for this study

Summary

The goal of this randomized, double-blind, placebo-controlled study is to investigate the effect of expectancy related to gluten consumption versus actual gluten intake on overall GI symptoms in individuals with non-coeliac gluten sensitivity (NCGS)

The main questions it aims to answer are:

* what is the effect of consumer expectancy, related to either gluten-containing or gluten-free oat bread, on short-term (within 8 hours) overall GI symptoms in individuals with NCGS?
* what is the effect of actual gluten intake on short-term (within 8 hours) overall GI symptoms in individuals with NCGS

Participants will be randomised into four groups:

1. Participants with the expectation of receiving gluten-containing bread and actually receiving gluten-containing oat bread during the test day. (E+ G+)
2. Participants with the expectation of receiving gluten-containing bread, but actually receiving gluten-free oat bread during the test day. (E+ G-)
3. Participants with the expectation of receiving gluten-free bread but actually receiving gluten-containing oat bread during the test day. (E- G+)
4. Participants with the expectation of receiving gluten-free bread and actually receiving gluten-free oat bread during the test day. (E- G-)

Conditions

  • Non-celiac Gluten Sensitivity

Interventions

OTHER

Expectancy and gluten

Effect of expectancy to receive gluten and/or actual gluten intake

Sponsors & Collaborators

  • University of Leeds

    collaborator OTHER

  • Wageningen University

    collaborator OTHER

  • Maastricht University

    lead OTHER

Principal Investigators

  • Daisy MAE Jonkers, Prof, PhD · Maastricht University

  • Louise Dye, Prof, PhD · University of Leeds

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-19
Primary Completion
2022-01-31
Completion
2022-02-15

Countries

  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05779358 on ClinicalTrials.gov