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Completed

NCT Number: NCT02592239

Hedonic Perception and Brain Activity Response to Meal

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.

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Key information

Conditions

Dyspepsia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vall d'Hebron Research Institute

Barcelona, 08035, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 80 yrs
  • Body mass index between 18-30 Kg/m2
  • Right-handed

Exclusion criteria

  • Subjects with clinical history of eating-disorders
  • Subjects with clinical history of significant head-trauma
  • Subjects with known serious illness: clinically significant cardiac, vascular, liver, pulmonary, or psychiatric disorders (as evaluated by the Investigator).
  • Subjects with a known history of alcohol or drug abuse in the previous 6 months.
  • Subjects using medications with SNS effects that cannot be discontinued, such as: antidepressants, pregabalin, gabapentin.
  • Women that are pregnant or that are breast-feeding.
  • Claustrophobia

Treatment and study plan

Functional brain MRI

Device

Functional brain MRI before and after test meal ingestion

A warm ham and cheese sandwich and a 200 ml fruit juice

Dietary Supplement

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 30, 2015
Registry last updated
Jul 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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