Back to resultsHedonic Perception and Brain Activity Response to Meal
Primary Purpose
Dyspepsia
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Functional brain MRI
A warm ham and cheese sandwich and a 200 ml fruit juice
Sponsored by
About this trial
This is an interventional diagnostic trial for Dyspepsia focused on measuring Functional brain MRI, functional dyspepsia, hedonic response
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 80 yrs
- Body mass index between 18-30 Kg/m2
- Right-handed
Exclusion Criteria:
- Subjects with clinical history of eating-disorders
- Subjects with clinical history of significant head-trauma
- Subjects with known serious illness: clinically significant cardiac, vascular, liver, pulmonary, or psychiatric disorders (as evaluated by the Investigator).
- Subjects with a known history of alcohol or drug abuse in the previous 6 months.
- Subjects using medications with SNS effects that cannot be discontinued, such as: antidepressants, pregabalin, gabapentin.
- Women that are pregnant or that are breast-feeding.
- Claustrophobia
Sites / Locations
- Vall d'Hebron Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patients
Controls
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Metabolomic response measured in serum by NMR spectroscopy
To identify the metabolomic substrate of the cognitive and brain responses to a meal.
Full Information
NCT ID
NCT02592239
First Posted
March 17, 2015
Last Updated
July 26, 2017
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02592239
Brief Title
Hedonic Perception and Brain Activity Response to Meal
Official Title
Hedonic Perception and Brain Activity Response to Meal in Health and Functional Dyspepsia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia
Keywords
Functional brain MRI, functional dyspepsia, hedonic response
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Controls
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Functional brain MRI
Intervention Description
Functional brain MRI before and after test meal ingestion
Intervention Type
Dietary Supplement
Intervention Name(s)
A warm ham and cheese sandwich and a 200 ml fruit juice
Primary Outcome Measure Information:
Title
Change in activity in specific brain regions measured by functional MRI
Description
To determine the brain response to a meal in patients with functional dyspepsia and healthy subjects.
Time Frame
3 hours
Title
Cognitive and hedonic perception measured on 10 score scales (composite outcome)
Description
To determine the cognitive and hedonic response to a meal in patients with functional dyspepsia and healthy subjects.
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Metabolomic response measured in serum by NMR spectroscopy
Description
To identify the metabolomic substrate of the cognitive and brain responses to a meal.
Time Frame
3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 80 yrs
Body mass index between 18-30 Kg/m2
Right-handed
Exclusion Criteria:
Subjects with clinical history of eating-disorders
Subjects with clinical history of significant head-trauma
Subjects with known serious illness: clinically significant cardiac, vascular, liver, pulmonary, or psychiatric disorders (as evaluated by the Investigator).
Subjects with a known history of alcohol or drug abuse in the previous 6 months.
Subjects using medications with SNS effects that cannot be discontinued, such as: antidepressants, pregabalin, gabapentin.
Women that are pregnant or that are breast-feeding.
Claustrophobia
Facility Information:
Facility Name
Vall d'Hebron Research Institute
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
25557693
Citation
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.
Results Reference
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PubMed Identifier
23874543
Citation
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.
Results Reference
background
PubMed Identifier
21684280
Citation
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.
Results Reference
background
PubMed Identifier
20160711
Citation
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.
Results Reference
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Hedonic Perception and Brain Activity Response to Meal
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