Brain ImagingNCT02618070
Cognitive Modulation of Dyspeptic Symptom During Food Ingestion in Functional Dyspepsia Patients Cognitive Modulation
A study testing Yogurt in people with Brain Imaging and Functional Dyspepsia, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
In this functional magnetic resonance imaging study, effects of different information of fat content of high or low fat will be examined in FD patients and healthy volunteers (n=30, respectively). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Imaging, Functional Dyspepsia, Food
- What is being tested?
- Yogurt
- 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
- Subjects which have a non-removable metal object in or at their body, such as, for example:
- Heart pace-maker,
- Artificial heart valve,
- Metal prosthesis,
- Metallic implants (screws, plates from operations, etc.),
- Interuterine Spiral,
Show all 11Show fewer
- Metalsplinters / grenade fragments
- Non-removable dental braces,
- Acupuncture needles,
- Insulin pump,
- Intraport, etc., Pregnant women or pregnancy cannot be excluded Nursing women Subjects with limited temperature perception and/or increased sensitivity to warming of the body A circulatory disease cannot be excluded Subjects with hearing-disease or an increased sensitivity to loud noises Subjects with fear of closed-in places (claustrophobia) Subjects which were operated less than three month ago Acute illness or infection Neurological disorder or injury (e.g. epilepsy) Moderate or severe head injury Severe psychotic illness (e.g. schizophrenia, depression) Intake of antidepressants / antipsychotics Vegetarians/Vegans Food allergies Self-reported eating disorder
Trial locations and contacts
1 site in 1 country.
Germany1 site
Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany
Tübingen, 72072
About this study
In this functional magnetic resonance imaging study, effects of different information of fat content of high or low fat will be examined in FD patients and healthy volunteers (n=30, respectively). These data will provide a better understanding of symptom generation following food ingestion in general as well as in patients with respective functional gastrointestinal disorders.
- Conditions
- Brain Imaging, Functional Dyspepsia, Food
- Being tested
- Yogurt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogurtOther
| Study group | Role | What they receive |
|---|---|---|
| Functional dyspepsia patient | Experimental | Yogurt ingestion Receives: Other: Yogurt |
| Healthy | Experimental | Yogurt ingestion Receives: Other: Yogurt |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional brain activity
Resting BOLD (Blood oxygenation level-dependent) signal before and after yogurt ingestion will compared between groups.
There is a small risk of discomfort from claustrophobia, periods of immobility, and exposure to the noise of the magnet. The investigators will offer the participants ear plugs. In rare cases the participants experience dizziness, nausea, or tinnitus which normally disappear after the measurement. During the measurements there is the possibility of warming which could lead to skin irritation in people with tattoos. Therefore, the participants with tattoos will not be included. The participants are instructed to tell the investigators immediately if any uncomforted appears. The study will be performed by experienced experimenters who know all about the risks. During the measurements, the participants are monitored. As a commercial yogurt (200 ml) will be used, the investigators do not expect any side effects. Food allergy will be checked before.
Measured: 1-2 years
subjective rating
The investigators will measure how much the participants have fullness, satiation, nausea and vomiting, pain, and their mood before and after the yogurt ingestion using 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 posted1 Dec 2015 (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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain ImagingStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- 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
- NCT02618070
- Sponsor's protocol ID
- 633/2015BO2
- Status last verified
- Apr 2017
- First submitted
- 24 Nov 2015
- Last updated
- 6 Apr 2017
- Results posted
- No
Publications
Lee IS, Kullmann S, Scheffler K, Preissl H, Enck P. Fat label compared with fat content: gastrointestinal symptoms and brain activity in functional dyspepsia patients and healthy controls. Am J Clin Nutr. 2018 Jul 1;108(1):127-135. doi: 10.1093/ajcn/nqy077.
PubMed 29924294
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
- Cognitive Modulation of Dyspeptic Symptom During Food Ingestion in Functional Dyspepsia Patients Cognitive Modulation
- ClinicalTrials.gov ID
- NCT02618070
- Acronym / sponsor ID
- 633/2015BO2
- Conditions
- Brain Imaging, Functional Dyspepsia, Food
- 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
- 1 Dec 2015 (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 this functional magnetic resonance imaging study, effects of different information of fat content of high or low fat will be examined in FD patients and healthy volunteers (n=30, respectively). These data will provide a better understanding of symptom generation following food ingestion in general as well as in patients with respective functional gastrointestinal disorders.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional dyspepsia patient | Experimental | Other: YogurtYogurt ingestion |
| Healthy | Experimental | Other: YogurtYogurt ingestion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 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 (11 listed)
- Subjects which have a non-removable metal object in or at their body, such as, for example:
- Heart pace-maker,
- Artificial heart valve,
- Metal prosthesis,
- Metallic implants (screws, plates from operations, etc.),
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 |
|---|---|---|
| Yogurt | Other | Functional dyspepsia patient, Healthy |
Primary outcome
functional brain activity
Time frame: 1-2 years
Resting BOLD (Blood oxygenation level-dependent) signal before and after yogurt ingestion will compared between groups. There is a small risk of discomfort from claustrophobia, periods of immobility, and exposure to the noise of the magnet. The investigators will offer the participants ear plugs. In rare cases the participants experience dizziness, nausea, or tinnitus which normally disappear after the measurement. During the measurements there is the possibility of warming which could lead to skin irritation in people with tattoos. Therefore, the participants with tattoos will not be included. The participants are instructed to tell the investigators immediately if any uncomforted appears. The study will be performed by experienced experimenters who know all about the risks. During the measurements, the participants are monitored. As a commercial yogurt (200 ml) will be used, the investigators do not expect any side effects. Food allergy will be checked before.
subjective rating
Time frame: 1-2 years
The investigators will measure how much the participants have fullness, satiation, nausea and vomiting, pain, and their mood before and after the yogurt ingestion using visual analog scale.
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.
- Derived from this study: PubMed 29924294Lee IS, Kullmann S, Scheffler K, Preissl H, Enck P. Fat label compared with fat content: gastrointestinal symptoms and brain activity in functional dyspepsia patients and healthy controls. Am J Clin Nutr. 2018 Jul 1;108(1):127-135. doi: 10.1093/ajcn/nqy077.
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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 Yogurt in people with Brain Imaging and 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 2 inclusion and 11 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?
functional brain activity (time frame: 1-2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02618070, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 7 Nov 2026.