Evidence map›Paper›PMID 40138597›Full record

Trial reportUnited European gastroenterology journal2025

Impact of Acute and Sub-Acute Gluten Exposure on Gastrointestinal Symptoms and Psychological Responses in Non-Coeliac Gluten Sensitivity: A Randomised Crossover Study.

Julie Iven, Annelies Geeraerts, Tim Vanuytsel, Jan Tack, Lukas Van Oudenhove, Jessica R Biesiekierski

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in United European gastroenterology journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03798249 naunknown statusnot on this map

Effect of Acute and Sub-acute Administration of Gluten on Extra-intestinal and Gastrointestinal Symptoms in Patients With Non-coeliac Gluten Sensitivity

TypeinterventionalSponsorUniversitaire Ziekenhuizen KU LeuvenRan2017 to 2022Enrolled20ConditionsNCGS, GlutenArmsGluten, Placebo
NCT03798262 nacompletednot on this map

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

TypeinterventionalSponsorUniversitaire Ziekenhuizen KU LeuvenRan2017 to 2018Enrolled20ConditionsHealthy Volunteers, GlutenArmsGluten, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Julie IvenDepartment of Chronic Diseases & Metabolism (CHROMETA), Translational Research Centre for Gastrointestinal Disorders (TARGID), KU Leuven, Leuven, Belgium.
Annelies GeeraertsDepartment of Chronic Diseases & Metabolism (CHROMETA), Translational Research Centre for Gastrointestinal Disorders (TARGID), KU Leuven, Leuven, Belgium.
Tim VanuytselDepartment of Chronic Diseases & Metabolism (CHROMETA), Translational Research Centre for Gastrointestinal Disorders (TARGID), KU Leuven, Leuven, Belgium.ORCID https://orcid.org/0000-0001-8728-0903
Jan TackDepartment of Chronic Diseases & Metabolism (CHROMETA), Translational Research Centre for Gastrointestinal Disorders (TARGID), KU Leuven, Leuven, Belgium.
Lukas Van OudenhoveDepartment of Chronic Diseases & Metabolism (CHROMETA), Translational Research Centre for Gastrointestinal Disorders (TARGID), KU Leuven, Leuven, Belgium.
Jessica R BiesiekierskiDepartment of Chronic Diseases & Metabolism (CHROMETA), Translational Research Centre for Gastrointestinal Disorders (TARGID), KU Leuven, Leuven, Belgium.

Funding

Fonds Wetenschappelijk Onderzoek 12G8915NFonds Wetenschappelijk Onderzoek 1517216NFonds Wetenschappelijk Onderzoek 1830517NFonds Wetenschappelijk Onderzoek G059822NNational Health and Medical Research Council APP2025943
6 · The paper itself

Abstract

BACKGROUND/

aimsNon-coeliac gluten sensitivity (NCGS) is a controversial entity, characterised by symptom improvement with gluten exclusion in the absence of coeliac disease. We primarily investigated the effects of acute and sub-acute gluten on psychological and mood profiles, with secondary outcomes examining gastrointestinal symptoms and biological markers in healthy controls (HC) and individuals with NCGS.

methodsA randomised, single-blind, crossover study used acute (16 g gluten or whey in yoghurt) and sub-acute (gluten-containing (16 g) or gluten-free muffins per day for 5 days) challenges. (Extra)intestinal symptoms, intestinal permeability, high-sensitive C-reactive protein and cortisol awakening response were assessed. Responses over time were analysed using generalised linear mixed models.

resultsTwenty HCs (15% men, mean age 30 years) and 16 individuals with NCGS (31% men, mean age 33 years) participated. No significant group-by-nutrient interactions were observed. Negative affect scores were higher and positive affect scores were lower in NCGS compared to HC (p = 0.01 and p = 0.04, respectively). Participants experienced higher tension scores after gluten compared with placebo (p = 0.01 acute; p = 0.05 sub-acute) regardless of the group. After acute administration, fatigue scores increased in NCGS (p = 0.03) compared with HC regardless of nutrient intake. After sub-acute administration, abdominal pain scores (p < 0.001) and bloating (p = 0.001) increased in NCGS compared with HC regardless of nutrient intake. No differences were found for biological markers.

conclusionsThese findings reveal that NCGS is characterised by baseline differences in affect, and higher acute fatigue and subacute gastrointestinal symptoms that are not gluten-specific. This may be explained by nocebo effects, warranting research into novel mechanisms and re-evaluating the NCGS definition.

trial registrationClinicalTrials.gov no: NCT03798262; NCT03798249.

Indexed as

Food HypersensitivityGlutensAbdominal PainAdultAffectBiomarkersCeliac DiseaseC-Reactive ProteinCross-Over StudiesDiet, Gluten-FreeFemaleHumansHydrocortisoneMaleSingle-Blind MethodYoung AdultBiomarkersC-Reactive ProteinGlutensHydrocortisoneFODMAPsgastrointestinal symptomsglutengluten‐free dietgluten‐related disordersnocebo effectnon‐coeliac gluten sensitivity (NCGS)psychological responses

Identifiers

PMID40138597
PMCPMC12463691

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.