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

Primary Purpose

Functional Dyspepsia

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

visual images

About this trial

This is an interventional basic science trial for Functional Dyspepsia focused on measuring skin conductance response, facial muscle activity, heart rate variability, eyetracking

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Functional dyspepsia patient

Healthy

Arm Description

Visual stimuli of food and non-food images will be presented to patients. Non-food images include positive, neutral, negative emotional pictures.

Visual stimuli of food and non-food images will be presented to participants. Non-food images include positive, neutral, negative emotional pictures.

Outcomes

Primary Outcome Measures

Psychological response

Skin conductance response

Psychological response

heart rate variability

Psychological response

facial muscle contraction

visual attention

eyemovement

Secondary Outcome Measures

Subjective rating

fullness (visual analog scale)

Subjective rating

satiation (visual analog scale)

Subjective rating

nausea (visual analog scale)

Subjective rating

pain (visual analog scale)

Subjective rating

mood (visual analog scale)

Full Information

NCT ID

NCT02727556

First Posted

March 21, 2016

Last Updated

April 5, 2017

Sponsor

University Hospital Tuebingen

1. Study Identification

Unique Protocol Identification Number

NCT02727556

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

April 2017 (Actual)

Study Completion Date

April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital Tuebingen

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Functional Dyspepsia

Keywords

skin conductance response, facial muscle activity, heart rate variability, eyetracking

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Functional dyspepsia patient

Arm Type

Experimental

Arm Description

Visual stimuli of food and non-food images will be presented to patients. Non-food images include positive, neutral, negative emotional pictures.

Arm Title

Healthy

Arm Type

Experimental

Arm Description

Visual stimuli of food and non-food images will be presented to participants. Non-food images include positive, neutral, negative emotional pictures.

Intervention Type

Behavioral

Intervention Name(s)

visual images

Primary Outcome Measure Information:

Title

Psychological response

Description

Skin conductance response

Time Frame

1-2 years

Title

Psychological response

Description

heart rate variability

Time Frame

1-2 years

Title

Psychological response

Description

facial muscle contraction

Time Frame

1-2 years

Title

visual attention

Description

eyemovement

Time Frame

1-2 years

Secondary Outcome Measure Information:

Title

Subjective rating

Description

fullness (visual analog scale)

Time Frame

1-2 years

Title

Subjective rating

Description

satiation (visual analog scale)

Time Frame

1-2 years

Title

Subjective rating

Description

nausea (visual analog scale)

Time Frame

1-2 years

Title

Subjective rating

Description

pain (visual analog scale)

Time Frame

1-2 years

Title

Subjective rating

Description

mood (visual analog scale)

Time Frame

1-2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Enck, Prof

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Tübingen

ZIP/Postal Code

72070

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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