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

University Hospital Tuebingen

Status: Completed

Conditions: Functional Dyspepsia; Food; Brain Imaging

Treatments: Other: Yogurt

Study type: Interventional

Funder types: Other

Identifiers

NCT02618070

633/2015BO2

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Functional dyspepsia patient

Experimental group

Description:

Yogurt ingestion

Treatment:

Other: Yogurt

Healthy

Experimental group

Description:

Yogurt ingestion

Treatment:

Other: Yogurt