Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-04-13 @ 11:07 AM
Study NCT ID:
NCT02727556
Status:
COMPLETED
Last Update Posted:
2017-04-06
First Post:
2016-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiological Response and Visual Attention to Visual Food Images in Healthy Subjects and in Functional Dyspepsia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-05', 'studyFirstSubmitDate': '2016-03-21', 'studyFirstSubmitQcDate': '2016-04-01', 'lastUpdatePostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychological response', 'timeFrame': '1-2 years', 'description': 'Skin conductance response'}, {'measure': 'Psychological response', 'timeFrame': '1-2 years', 'description': 'heart rate variability'}, {'measure': 'Psychological response', 'timeFrame': '1-2 years', 'description': 'facial muscle contraction'}, {'measure': 'visual attention', 'timeFrame': '1-2 years', 'description': 'eyemovement'}], 'secondaryOutcomes': [{'measure': 'Subjective rating', 'timeFrame': '1-2 years', 'description': 'fullness (visual analog scale)'}, {'measure': 'Subjective rating', 'timeFrame': '1-2 years', 'description': 'satiation (visual analog scale)'}, {'measure': 'Subjective rating', 'timeFrame': '1-2 years', 'description': 'nausea (visual analog scale)'}, {'measure': 'Subjective rating', 'timeFrame': '1-2 years', 'description': 'pain (visual analog scale)'}, {'measure': 'Subjective rating', 'timeFrame': '1-2 years', 'description': 'mood (visual analog scale)'}]}, 'conditionsModule': {'keywords': ['skin conductance response', 'facial muscle activity', 'heart rate variability', 'eyetracking'], 'conditions': ['Functional Dyspepsia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* Visual impairment Severe psychiatric illness (e.g. schizophrenia, severe depression (BDI-II:29-63)), substance dependence and abuse Intake of antidepressants / antipsychotics'}, 'identificationModule': {'nctId': 'NCT02727556', 'briefTitle': 'Physiological Response and Visual Attention to Visual Food Images in Healthy Subjects and in Functional Dyspepsia Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'orgStudyIdInfo': {'id': '041/2016BO2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Functional dyspepsia patient', 'description': 'Visual stimuli of food and non-food images will be presented to patients. Non-food images include positive, neutral, negative emotional pictures.', 'interventionNames': ['Behavioral: visual images']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy', 'description': 'Visual stimuli of food and non-food images will be presented to participants. Non-food images include positive, neutral, negative emotional pictures.', 'interventionNames': ['Behavioral: visual images']}], 'interventions': [{'name': 'visual images', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Functional dyspepsia patient', 'Healthy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72070', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Paul Enck, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MS', 'investigatorFullName': 'Inseon Lee', 'investigatorAffiliation': 'University Hospital Tuebingen'}}}}