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Hedonic Perception and Brain Activity Response to Meal

V

Vall d'Hebron University Hospital (HUVH)

Status

Completed

Conditions

Dyspepsia

Treatments

Device: Functional brain MRI
Dietary Supplement: A warm ham and cheese sandwich and a 200 ml fruit juice

Study type

Interventional

Funder types

Other

Identifiers

NCT02592239
PR(AG)214/2012 Addendum

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Patients
Experimental group
Description:
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.
Treatment:
Dietary Supplement: A warm ham and cheese sandwich and a 200 ml fruit juice
Device: Functional brain MRI
Controls
Experimental group
Description:
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.
Treatment:
Dietary Supplement: A warm ham and cheese sandwich and a 200 ml fruit juice
Device: Functional brain MRI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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