Hedonic Perception and Brain Activity Response to Meal

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592239
• Other study ID #: PR(AG)214/2012 Addendum
• Status: Completed
• Phase: N/A
• First received: March 17, 2015
• Last updated: July 26, 2017
• Start date: November 2014
• Est. completion date: June 30, 2017

Study information

• Verified date: September 2016
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 30, 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia

Intervention

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

Locations

Country	Name	City	State
Spain	Vall d'Hebron Research Institute	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Metabolomic response measured in serum by NMR spectroscopy	To identify the metabolomic substrate of the cognitive and brain responses to a meal.	3 hours