Hedonic Perception and Brain Activity Response to Meal

Not Applicable

Completed

• Conditions: Dyspepsia
• Interventions: Device: Functional brain MRI; Dietary Supplement: A warm ham and cheese sandwich and a 200 ml fruit juice

• Registration Number: NCT02592239
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-03-17
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Status Verified: 2016-09
• Primary Completion: 2017-06
• Study Completion: 2017-06-30
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients	Functional brain MRI	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.
Controls	Functional brain MRI	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.
Patients	A warm ham and cheese sandwich and a 200 ml fruit juice	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.
Controls	A warm ham and cheese sandwich and a 200 ml fruit juice	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.

Primary Outcome Measures

Name	Time	Method
Change in activity in specific brain regions measured by functional MRI	3 hours	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)	3 hours	To determine the cognitive and hedonic response to a meal in patients with functional dyspepsia and healthy subjects.

Secondary Outcome Measures

Name	Time	Method
Metabolomic response measured in serum by NMR spectroscopy	3 hours	To identify the metabolomic substrate of the cognitive and brain responses to a meal.

Trial Locations

Locations (1)

Vall d'Hebron Research Institute; 🇪🇸 Barcelona, Spain