Hedonic Perception and Brain Activity Response to Meal

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

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.

Study Overview

• Status: Completed
• Conditions: Dyspepsia
• Intervention / Treatment: Device: Functional brain MRI; Dietary supplement: A warm ham and cheese sandwich and a 200 ml fruit juice

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Vall d'Hebron Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Functional brain MRI before and after test meal ingestion; 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; Functional brain MRI before and after test meal ingestion; Dietary supplement: A warm ham and cheese sandwich and a 200 ml fruit juice

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: March 17, 2015
• First Submitted That Met QC Criteria: October 29, 2015
• First Posted (Estimate): October 30, 2015

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 26, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Functional brain MRI; functional dyspepsia; hedonic response
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: PR(AG)214/2012 Addendum

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No