Hedonic Perception and Brain Activity Response to Meal

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Dyspepsia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Functional brain MRI

Intervention Type DEVICE

Functional brain MRI before and after test meal ingestion

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

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type EXPERIMENTAL

Functional brain MRI

Intervention Type DEVICE

Functional brain MRI before and after test meal ingestion

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

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Functional brain MRI

Functional brain MRI before and after test meal ingestion

Intervention Type DEVICE

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes