Healthy Volunteers, GlutenNCT03798262
Effect of Acute and Sub-acute Administration of Gluten on Extra-intestinal and Gastrointestinal Symptoms in Healthy Subjects
A study testing Gluten in people with Healthy Volunteers, Gluten, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Gluten
- What is being tested?
- Gluten
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesBelgium
- Study dates
- 16 Feb 2017to 2 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) of 20 - 25 kg/m2
- Stable body weight for at least 3 months prior to the start of the study
Who cannot join
- 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
Show all 19Show fewer
- 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 locations and contacts
2 sites in 1 country.
About this study
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
- Being tested
- Gluten, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutenOther
Tereos
PlaceboOther
Whey protein from Nestlé Healthy Science
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Gluten |
| Placebo | Placebo comparator | Patients receive 16 g of whey protein acutely and afterwards 2 glutenfree muffins for 5 days sub-acutely Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Scores are measured on the Visual Analogue Scale. With '0' no complaints and '10' a lot of complaints (change from baseline).
Measured: 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)
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
Measured: 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
Change in high sensitive reactive protein levels measured at day 0, day 21 and day 41.
Measured: 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
Change in lipopolysaccharide-binding protein levels measured at day 0, day 21 and day 41.
Measured: 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
Change in lipopolysaccharide levels measured at day 0, day 21 and day 41.
Measured: 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 gut microbiota composition (stool samples)
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.
Measured: 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
Effect of acute and sub-acute gluten administration on cortisol awakening response (saliva samples)
Change in cortisol levels between gluten and placebo administration (saliva samples). Measured using an ELISA assay.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start16 Feb 2017
- Primary completion2 Apr 2018
- Study completion2 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Volunteers, GlutenStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- single-blinded, randomised controlled, cross-over study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dr Jan Tack, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798262
- Sponsor's protocol ID
- S58915
- Status last verified
- Jan 2019
- First submitted
- 11 Oct 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40138597
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acute and Sub-acute Administration of Gluten on Extra-intestinal and Gastrointestinal Symptoms in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03798262
- Acronym / sponsor ID
- S58915
- Conditions
- Healthy Volunteers, Gluten
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 2 Apr 2018 (actual)
- First posted
- 9 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- single-blinded, randomised controlled, cross-over study
| Arm | Type | Receives |
|---|---|---|
| Gluten | Active comparator | Other: GlutenPatients receive 16 g of gluten acutely and afterwards 2 glutenfree muffins with 8 g of gluten for 5 days sub-acutely |
| Placebo | Placebo comparator | Other: PlaceboPatients receive 16 g of whey protein acutely and afterwards 2 glutenfree muffins for 5 days sub-acutely |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI) of 20 - 25 kg/m2
- Stable body weight for at least 3 months prior to the start of the study
Key exclusion criteria (19 listed)
- Medical
- Psychiatric disorders
- Eating disorders
- Depressive disorders
- Anxiety disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlutenTereos | Other | Gluten |
| PlaceboWhey protein from Nestlé Healthy Science | Other | Placebo |
Primary outcome
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.
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.
7 secondary outcomes
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)
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)
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)
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)
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)
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Derived from this study: PubMed 40138597Iven 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten in people with Healthy Volunteers, Gluten, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03798262, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.