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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Healthy Volunteers, Gluten

Treatments: Other: Placebo; Other: Gluten

Study type: Interventional

Funder types: Other

Identifiers

NCT03798262

S58915

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

20 participants in 2 patient groups, including a placebo group

Gluten

Active Comparator group

Description:

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

Treatment:

Other: Gluten

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo