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CompletedNCT02592239Updated Jul 27, 2017

Hedonic Perception and Brain Activity Response to Meal

An interventional study of Functional brain MRI and A warm ham and cheese sandwich and a 200 ml fruit juice in Dyspepsia, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Completed at 1 site in Spain. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-27.

Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

The purpose of this study is to determine the relationship between brain activity and the perception of subjective hedonic sensations in response to a meal using functional MRI.

Read the detailed description

Functional MRI brain imaging will be performed in patients with functional dyspepsia and healthy controls in basal conditions and after a palatable test meal. During the study, the cognitive response and the hedonic dimension will be measured using 10 score scales.

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Conditions studied

  • Dyspepsia

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Keywords

  • Functional brain MRI
  • functional dyspepsia
  • hedonic response
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In context

Dyspepsia

363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.

This study's enrollment of 80 is close to the median of 87 across 297 interventional studies indexed under Dyspepsia.

Browse Dyspepsia studies →

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age between 18 and 80 yrs
  2. Body mass index between 18-30 Kg/m2
  3. Right-handed

Exclusion criteria

Exclusion Criteria:

  1. Subjects with clinical history of eating-disorders
  2. Subjects with clinical history of significant head-trauma
  3. Subjects with known serious illness: clinically significant cardiac, vascular, liver, pulmonary, or psychiatric disorders (as evaluated by the Investigator).
  4. Subjects with a known history of alcohol or drug abuse in the previous 6 months.
  5. Subjects using medications with SNS effects that cannot be discontinued, such as: antidepressants, pregabalin, gabapentin.
  6. Women that are pregnant or that are breast-feeding.
  7. Claustrophobia
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Patients

    Functional dyspepsia patients will be studied using functional brain MRI before and after receiving a test meal. Cognitive and hedonic response will be evaluated using 10 score scales.

    Device: Functional brain MRI · Dietary Supplement: A warm ham and cheese sandwich and a 200 ml fruit juice

  • Experimental
    Controls

    Healthy subjects recruited by public advertisement will be studied using functional brain MRI before and after receiving a test meal. Cognitive and hedonic response will be evaluated using 10 score scales.

    Device: Functional brain MRI · Dietary Supplement: A warm ham and cheese sandwich and a 200 ml fruit juice

Interventions

  • DeviceFunctional brain MRI

    Functional brain MRI before and after test meal ingestion

  • Dietary supplementA warm ham and cheese sandwich and a 200 ml fruit juice
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What researchers measure

Primary outcomes

  1. Change in activity in specific brain regions measured by functional MRI

    To determine the brain response to a meal in patients with functional dyspepsia and healthy subjects.

    Time frame: 3 hours

  2. Cognitive and hedonic perception measured on 10 score scales (composite outcome)

    To determine the cognitive and hedonic response to a meal in patients with functional dyspepsia and healthy subjects.

    Time frame: 3 hours

Secondary outcomes

  1. Metabolomic response measured in serum by NMR spectroscopy

    To identify the metabolomic substrate of the cognitive and brain responses to a meal.

    Time frame: 3 hours

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Study locations

1 site
  • Vall d'Hebron Research Institute
    Barcelona, 08035, Spain
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References and documents

Publications

  • Malagelada C, Accarino A, Molne L, Mendez S, Campos E, Gonzalez A, Malagelada JR, Azpiroz F. Digestive, cognitive and hedonic responses to a meal. Neurogastroenterol Motil. 2015 Mar;27(3):389-96. doi: 10.1111/nmo.12504. Epub 2015 Jan 3. PubMed 25557693 ↗
  • Liu P, Qin W, Wang J, Zeng F, Zhou G, Wen H, von Deneen KM, Liang F, Gong Q, Tian J. Identifying neural patterns of functional dyspepsia using multivariate pattern analysis: a resting-state FMRI study. PLoS One. 2013 Jul 12;8(7):e68205. doi: 10.1371/journal.pone.0068205. Print 2013. PubMed 23874543 ↗
  • Zeng F, Qin W, Liang F, Liu J, Tang Y, Liu X, Yuan K, Yu S, Song W, Liu M, Lan L, Gao X, Liu Y, Tian J. Abnormal resting brain activity in patients with functional dyspepsia is related to symptom severity. Gastroenterology. 2011 Aug;141(2):499-506. doi: 10.1053/j.gastro.2011.05.003. Epub 2011 May 17. PubMed 21684280 ↗
  • Van Oudenhove L, Vandenberghe J, Dupont P, Geeraerts B, Vos R, Dirix S, Bormans G, Vanderghinste D, Van Laere K, Demyttenaere K, Fischler B, Tack J. Abnormal regional brain activity during rest and (anticipated) gastric distension in functional dyspepsia and the role of anxiety: a H(2)(15)O-PET study. Am J Gastroenterol. 2010 Apr;105(4):913-24. doi: 10.1038/ajg.2010.39. Epub 2010 Feb 16. PubMed 20160711 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02592239
Lead sponsor
Hospital Universitari Vall d'Hebron Research Institute
Responsible party
Sponsor
First posted
Oct 30, 2015
Start date
Nov 2014
Primary completion
Jun 2017
Completion
Jun 30, 2017
Last update
Jul 27, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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