Clinical trial NCT02592239: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dyspepsia
Keywords: Functional brain MRI
functional dyspepsia
hedonic response
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2015-10-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in activity in specific brain regions measured by functional MRI
timeFrame: 3 hours
measure: Cognitive and hedonic perception measured on 10 score scales (composite outcome)
timeFrame: 3 hours
Secondary outcomes:
measure: Metabolomic response measured in serum by NMR spectroscopy
timeFrame: 3 hours
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebron Research Institute
Study officials:
References:
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.
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.
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.
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.