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Hedonic Perception and Brain Activity Response to Meal

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ClinicalTrials.gov Identifier: NCT02592239
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dyspepsia Device: Functional brain MRI Dietary Supplement: A warm ham and cheese sandwich and a 200 ml fruit juice Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Hedonic Perception and Brain Activity Response to Meal in Health and Functional Dyspepsia
Study Start Date : November 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

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



Primary Outcome Measures :
  1. Change in activity in specific brain regions measured by functional MRI [ Time Frame: 3 hours ]
    To determine the brain response to a meal in patients with functional dyspepsia and healthy subjects.

  2. Cognitive and hedonic perception measured on 10 score scales (composite outcome) [ Time Frame: 3 hours ]
    To determine the cognitive and hedonic response to a meal in patients with functional dyspepsia and healthy subjects.


Secondary Outcome Measures :
  1. Metabolomic response measured in serum by NMR spectroscopy [ Time Frame: 3 hours ]
    To identify the metabolomic substrate of the cognitive and brain responses to a meal.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592239


Locations
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Spain
Vall d'Hebron Research Institute
Barcelona, Spain, 08035
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute

Publications:
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT02592239     History of Changes
Other Study ID Numbers: PR(AG)214/2012 Addendum
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: September 2016

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Functional brain MRI
functional dyspepsia
hedonic response

Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms