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CompletedNCT02618070Updated Apr 6, 2017

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

An interventional study of Yogurt in Brain Imaging, Functional Dyspepsia and Food, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-06.

Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Brain Imaging
  • Functional Dyspepsia
  • Food

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In context

Dyspepsia

363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.

This study's planned enrollment of 30 is below the median of 87 across 297 interventional studies indexed under Dyspepsia.

Browse Dyspepsia studies →

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Functional dyspepsia patient

    Yogurt ingestion

    Other: Yogurt

  • Experimental
    Healthy

    Yogurt ingestion

    Other: Yogurt

Interventions

  • OtherYogurt
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1-2 years

  2. 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.

    Time frame: 1-2 years

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Study locations

1 site
  • Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany
    Tuebingen, 72072, Germany
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02618070
Lead sponsor
University Hospital Tuebingen
Responsible party
Inseon Lee (MS, University Hospital Tuebingen) — Principal investigator
First posted
Dec 1, 2015
Start date
Mar 2016
Primary completion
Apr 2017
Completion
Apr 2017
Last update
Apr 6, 2017

Study contacts

Paul Enck, Prof.
principal investigator · Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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