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Completed

NCT Number: NCT02727556

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

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.

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Key information

Conditions

Functional Dyspepsia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Tübingen, 72070, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

visual images

Behavioral

Primary outcomes

  1. Psychological response

    Time frame: 1-2 years

    Skin conductance response

  2. Psychological response

    Time frame: 1-2 years

    heart rate variability

  3. Psychological response

    Time frame: 1-2 years

    facial muscle contraction

  4. visual attention

    Time frame: 1-2 years

    eyemovement

Secondary outcomes

  1. Subjective rating

    Time frame: 1-2 years

    fullness (visual analog scale)

  2. Subjective rating

    Time frame: 1-2 years

    satiation (visual analog scale)

  3. Subjective rating

    Time frame: 1-2 years

    nausea (visual analog scale)

  4. Subjective rating

    Time frame: 1-2 years

    pain (visual analog scale)

  5. Subjective rating

    Time frame: 1-2 years

    mood (visual analog scale)

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 4, 2016
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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