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

Functional Dyspepsia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727556
• Other study ID #: 041/2016BO2
• Status: Completed
• Phase: N/A
• First received: March 21, 2016
• Last updated: April 5, 2017
• Start date: March 2016
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Intervention

Behavioral:
• visual images

Locations

Country	Name	City	State
Germany	Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological response	Skin conductance response	1-2 years
Primary	Psychological response	heart rate variability	1-2 years
Primary	Psychological response	facial muscle contraction	1-2 years
Primary	visual attention	eyemovement	1-2 years
Secondary	Subjective rating	fullness (visual analog scale)	1-2 years
Secondary	Subjective rating	satiation (visual analog scale)	1-2 years
Secondary	Subjective rating	nausea (visual analog scale)	1-2 years
Secondary	Subjective rating	pain (visual analog scale)	1-2 years
Secondary	Subjective rating	mood (visual analog scale)	1-2 years