Physiological Response and Visual Attention to Visual Food Images in Healthy Subjects and in Functional Dyspepsia Patients

April 5, 2017 updated by: Inseon Lee, University Hospital Tuebingen
In functional dyspepsia (FD), abnormal cognitive and emotional changes such increased sensitization, anxiety, and depression scores have been reported in addition to the peripheral changes in gastrointestinal tract functions. In this study, investigators will evaluate the activity of autonomic nervous system, emotional response, and visual attention to food and non-food images in 30 male and female FD patients and 30 age/gender-matched healthy volunteers. These data will provide a new finding of the influence of impaired cognitive processing of food on symptom generation in functional gastrointestinal disorder patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tübingen, Germany, 72070
        • Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female, volunteering adults BMI: 18-25 kg/m² right-handed Age: 18-65 years Capacity to give informed consent For FD patients, Diagnosis of functional dyspepsia over the last 12 months certified by a medical record Inconspicuous gastroscopy during the last 6 months certified by a medical record

Exclusion Criteria:

  • Visual impairment Severe psychiatric illness (e.g. schizophrenia, severe depression (BDI-II:29-63)), substance dependence and abuse Intake of antidepressants / antipsychotics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Functional dyspepsia patient
Visual stimuli of food and non-food images will be presented to patients. Non-food images include positive, neutral, negative emotional pictures.
Behavioral: visual images
Experimental: Healthy
Visual stimuli of food and non-food images will be presented to participants. Non-food images include positive, neutral, negative emotional pictures.
Behavioral: visual images

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological response
Time Frame: 1-2 years
Skin conductance response
1-2 years
Psychological response
Time Frame: 1-2 years
heart rate variability
1-2 years
Psychological response
Time Frame: 1-2 years
facial muscle contraction
1-2 years
visual attention
Time Frame: 1-2 years
eyemovement
1-2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective rating
Time Frame: 1-2 years
fullness (visual analog scale)
1-2 years
Subjective rating
Time Frame: 1-2 years
satiation (visual analog scale)
1-2 years
Subjective rating
Time Frame: 1-2 years
nausea (visual analog scale)
1-2 years
Subjective rating
Time Frame: 1-2 years
pain (visual analog scale)
1-2 years
Subjective rating
Time Frame: 1-2 years
mood (visual analog scale)
1-2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Paul Enck, Prof, Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

March 21, 2016

First Submitted That Met QC Criteria

April 1, 2016

First Posted (Estimate)

April 4, 2016

Study Record Updates

Last Update Posted (Actual)

April 6, 2017

Last Update Submitted That Met QC Criteria

April 5, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 041/2016BO2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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