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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-16

Study Completion Date

2018-04-02

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Volunteers, Gluten

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

single-blinded, randomised controlled, cross-over study

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Gluten

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

Group Type ACTIVE_COMPARATOR

Gluten

Intervention Type OTHER

Tereos

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Whey protein from Nestlé Healthy Science

Interventions

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Gluten

Tereos

Intervention Type OTHER

Placebo

Whey protein from Nestlé Healthy Science

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes