Hedonic Perception and Brain Activity Response to Meal

Study Overview
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Brief Summary
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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
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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.

Official Title
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Hedonic Perception and Brain Activity Response to Meal in Health and Functional Dyspepsia

Conditions
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Dyspepsia

Intervention / Treatment
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* Device: Functional brain MRI
* Dietary Supplement: A warm ham and cheese sandwich and a 200 ml fruit juice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>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<br>* Functional brain MRI before and after test meal ingestion<br>Dietary Supplement: A warm ham and cheese sandwich and a 200 ml fruit juice<br> <br> |
| Experimental: Controls<br>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<br>* Functional brain MRI before and after test meal ingestion<br>Dietary Supplement: A warm ham and cheese sandwich and a 200 ml fruit juice<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 hours | 
| 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. | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolomic response measured in serum by NMR spectroscopy | To identify the metabolomic substrate of the cognitive and brain responses to a meal. | 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional brain MRI, functional dyspepsia, hedonic response