Back to resultsCognitive Modulation of Dyspeptic Symptom During Food Ingestion in Functional Dyspepsia Patients Cognitive Modulation
Primary Purpose
Brain Imaging, Functional Dyspepsia, Food
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Yogurt
Sponsored by
About this trial
This is an interventional basic science trial for Brain Imaging
Eligibility Criteria
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:
- 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,
- 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
Sites / Locations
- Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Functional dyspepsia patient
Healthy
Arm Description
Yogurt ingestion
Yogurt ingestion
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02618070
First Posted
November 24, 2015
Last Updated
April 5, 2017
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT02618070
Brief Title
Cognitive Modulation of Dyspeptic Symptom During Food Ingestion in Functional Dyspepsia Patients Cognitive Modulation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Imaging, Functional Dyspepsia, Food
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Functional dyspepsia patient
Arm Type
Experimental
Arm Description
Yogurt ingestion
Arm Title
Healthy
Arm Type
Experimental
Arm Description
Yogurt ingestion
Intervention Type
Other
Intervention Name(s)
Yogurt
Primary Outcome Measure Information:
Title
functional brain activity
Description
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.
Time Frame
1-2 years
Title
subjective rating
Description
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.
Time Frame
1-2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
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,
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Enck, Prof.
Organizational Affiliation
Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany
City
Tuebingen
ZIP/Postal Code
72072
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
29924294
Citation
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.
Results Reference
derived
Learn more about this trial
Cognitive Modulation of Dyspeptic Symptom During Food Ingestion in Functional Dyspepsia Patients Cognitive Modulation
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