Functional DyspepsiaNCT02727556
Physiological Response and Visual Attention to Visual Food Images in Healthy Subjects and in Functional Dyspepsia Patients
A study testing visual images in people with Functional Dyspepsia, run by University Hospital Tuebingen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- visual images
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Visual impairment Severe psychiatric illness (e.g. schizophrenia, severe depression (BDI-II:29-63)), substance dependence and abuse Intake of antidepressants / antipsychotics
Trial locations and contacts
1 site in 1 country.
Germany1 site
Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany
Tübingen, 72070
About this study
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
- Being tested
- visual images
- Keywords
- skin conductance response, facial muscle activity, heart rate variability, eyetracking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual imagesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: visual images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological response
Skin conductance response
Measured: 1-2 years
Psychological response
heart rate variability
Measured: 1-2 years
Psychological response
facial muscle contraction
Measured: 1-2 years
visual attention
eyemovement
Measured: 1-2 years
Secondary outcomes (5)
Subjective rating
fullness (visual analog scale)
Measured: 1-2 years
Subjective rating
satiation (visual analog scale)
Measured: 1-2 years
Subjective rating
nausea (visual analog scale)
Measured: 1-2 years
Subjective rating
pain (visual analog scale)
Measured: 1-2 years
Subjective rating
mood (visual analog scale)
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inseon Lee, University Hospital Tuebingen
- Investigators
- Paul Enck, Prof, Principal investigator, Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727556
- Sponsor's protocol ID
- 041/2016BO2
- Status last verified
- Apr 2017
- First submitted
- 21 Mar 2016
- Last updated
- 6 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Response and Visual Attention to Visual Food Images in Healthy Subjects and in Functional Dyspepsia Patients
- ClinicalTrials.gov ID
- NCT02727556
- Acronym / sponsor ID
- 041/2016BO2
- Conditions
- Functional Dyspepsia
- Keywords
- skin conductance response, facial muscle activity, heart rate variability, eyetracking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional dyspepsia patient | Experimental | Behavioral: visual imagesVisual stimuli of food and non-food images will be presented to patients. Non-food images include positive, neutral, negative emotional pictures. |
| Healthy | Experimental | Behavioral: visual imagesVisual stimuli of food and non-food images will be presented to participants. Non-food images include positive, neutral, negative emotional pictures. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Visual impairment Severe psychiatric illness (e.g. schizophrenia, severe depression (BDI-II:29-63)), substance dependence and abuse Intake of antidepressants / antipsychotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| visual images | Behavioural | Functional dyspepsia patient, Healthy |
Primary outcome
Psychological response
Time frame: 1-2 years
Skin conductance response
Psychological response
Time frame: 1-2 years
heart rate variability
Psychological response
Time frame: 1-2 years
facial muscle contraction
visual attention
Time frame: 1-2 years
eyemovement
5 secondary outcomes
Subjective rating
Time frame: 1-2 years
Subjective rating
Time frame: 1-2 years
Subjective rating
Time frame: 1-2 years
Subjective rating
Time frame: 1-2 years
Subjective rating
Time frame: 1-2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Enck, Prof principal investigator
Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visual images in people with Functional Dyspepsia, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological response (time frame: 1-2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.