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

NCT ID: NCT02727556

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-04-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

visual images

Intervention Type: BEHAVIORAL

Healthy

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

Group Type: EXPERIMENTAL

visual images

Intervention Type: BEHAVIORAL

Interventions

visual images

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Inseon Lee

MS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Enck, Prof

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Tübingen, , Germany

Countries

Germany

Other Identifiers

041/2016BO2

Identifier Type: -

Identifier Source: org_study_id