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Cognitive Modulation of Dyspeptic Symptom During Food Ingestion in Functional Dyspepsia Patients Cognitive Modulation

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ClinicalTrials.gov Identifier: NCT02618070
Recruitment Status : Completed
First Posted : December 1, 2015
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Inseon Lee, University Hospital Tuebingen

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.

Condition or disease Intervention/treatment Phase
Brain Imaging Functional Dyspepsia Food Other: Yogurt Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Study Start Date : March 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Experimental: Functional dyspepsia patient
Yogurt ingestion
Other: Yogurt
Experimental: Healthy
Yogurt ingestion
Other: Yogurt



Primary Outcome Measures :
  1. 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.


  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618070


Locations
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Germany
Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany
Tuebingen, Germany, 72072
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Paul Enck, Prof. Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Inseon Lee, MS, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02618070     History of Changes
Other Study ID Numbers: 633/2015BO2
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms