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

Functional Dyspepsia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618070
• Other study ID #: 633/2015BO2
• Status: Completed
• Phase: N/A
• First received: November 24, 2015
• Last updated: April 5, 2017
• Start date: March 2016
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Imaging
• Dyspepsia
• Food
• Functional Dyspepsia

Intervention

Other:
• Yogurt

Locations

Country	Name	City	State
Germany	Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1-2 years
Primary	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.	1-2 years