NCT02618070

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 6, 2017

Status Verified

April 1, 2017

Enrollment Period

1.1 years

First QC Date

November 24, 2015

Last Update Submit

April 5, 2017

Conditions

Brain ImagingFunctional DyspepsiaFood

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Functional dyspepsia patient

EXPERIMENTAL

Yogurt ingestion

Other: Yogurt

Healthy

EXPERIMENTAL

Yogurt ingestion

Other: Yogurt

Interventions

YogurtOTHER
Functional dyspepsia patientHealthy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany

Tübingen, 72072, Germany

Location

Related Publications (1)

  • 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.

    PMID: 29924294DERIVED

MeSH Terms

Interventions

Yogurt

Intervention Hierarchy (Ancestors)

Cultured Milk ProductsMilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaFermented FoodsDairy ProductsFoodFood and Beverages

Study Officials

  • Paul Enck, Prof.

    Psychosomatic Medicine and Psychotherapy Department, University of Tübingen, Tübingen, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MS

Study Record Dates

First Submitted

November 24, 2015

First Posted

December 1, 2015

Study Start

March 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

April 6, 2017

Record last verified: 2017-04

Locations

DE(1)