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

NCT02727556 | Completed

• 1 other identifier: 041/2016BO2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Dyspepsia

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Psychological response

  Skin conductance response

  1-2 years

• Psychological response

  heart rate variability

  1-2 years

• Psychological response

  facial muscle contraction

  1-2 years

• visual attention

  eyemovement

  1-2 years

Secondary Outcomes (5)

• Subjective rating

  1-2 years

• Subjective rating

  1-2 years

• Subjective rating

  1-2 years

• Subjective rating

  1-2 years

• Subjective rating

  1-2 years

Study Arms (2)

Functional dyspepsia patient

EXPERIMENTAL

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

Healthy

EXPERIMENTAL

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

Interventions

visual images BEHAVIORAL

Functional dyspepsia patient; Healthy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

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

Tübingen, 72070, Germany

Location

Study Officials

• Paul Enck, Prof

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MS

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: April 4, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 6, 2017

Record last verified: 2017-04

Locations

DE (1)