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Responses to a Comfort Meal in Functional Dyspepsia

Primary Purpose

Functional Gastrointestinal Disorders

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Probe meal

About this trial

This is an interventional other trial for Functional Gastrointestinal Disorders focused on measuring meal ingestion, postprandial responses, hedonic sensations, homeostatic sensations, functional dyspepsia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria for Patients with Functional Dyspepsia:

Rome IV Criteria for Functional Dyspepsia

Inclusion Criteria for Healthy Subjects

absence of digestive symptoms

Exclusion Criteria for all participants:

history of anosmia and ageusia
alcohol abuse
psychological disorders
eating disorders

Inclusion Criteria for Healthy Subjects:

non-obese

Exclusion Criteria:

history of gastrointestinal symptoms
prior obesity
use of medications
history of anosmia and ageusia
current dieting
alcohol abuse
psychological disorders
eating disorders

Sites / Locations

Hospital Vall d'Hebron

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Functional dyspepsia

Healthy subjects

Arm Description

Outcomes

Primary Outcome Measures

Meal enjoyment

Amount of meal (Kcal) consumed up to the level of maximal digestive well-being measured on a - 5 (extremely unpleasant sensation) to + 5 scale (extremely pleasant sensation).

Secondary Outcome Measures

Change in digestive well-being induced by the probe meal

Change in well-being measured by 10 score scales during and after the probe meal.

Change in fullness sensation induced by the probe meal

Change in fullness sensation measured by 10 score scales during and after the probe meal.

Change in mood induced by the probe meal

Change in mood measured by 10 score scales during and after the probe meal.

Change in abdominal discomfort induced by the probe meal

Change in abdominal discomfort measured by 10 score scales during and after the probe meal.

Change in hunger/satiety induced by the probe meal

Change in hunger/satiety measured by 10 score scales during and after the probe meal.

Full Information

NCT ID

NCT04722419

First Posted

January 21, 2021

Last Updated

February 6, 2022

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT04722419

Brief Title

Responses to a Comfort Meal in Functional Dyspepsia

Official Title

Factors That Determine the Responses to Meal Ingestion in Functional Dyspepsia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

February 2, 2021 (Actual)

Primary Completion Date

September 30, 2021 (Actual)

Study Completion Date

December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Background. Dyspeptic patients tolerate smaller meal loads than healthy subjects, but it is not known whether and to what extent symptoms relate to abnormal homeostatic or hedonic components of perception. Methods. Parallel studies in patients with symptoms induced by meals (fulfilling Rome IV criteria of postprandial dyspepsia) and sex- and age-matched healthy subjects. Participants will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 4 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Participants will ingest a probe meal up to the level of maximal satiation. The probe meal will be served stepwise (112 Kcal every 5 min). Perception of homeostatic (hunger/satiation, fullness) and hedonic (digestive well-being, mood) sensations will be measured at 5 min intervals 10 min before, during and 20 min after ingestion at 10 min intervals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Functional Gastrointestinal Disorders

Keywords

meal ingestion, postprandial responses, hedonic sensations, homeostatic sensations, functional dyspepsia

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Functional dyspepsia

Arm Type

Experimental

Arm Title

Healthy subjects

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Probe meal

Intervention Description

The probe meal will be served in 112 Kcal portions (16 g white bread, 10 g cheese, 10 g jam, 3.25 g butter, and 50 mL orange juice) up to the level of maximal satiation.

Primary Outcome Measure Information:

Title

Meal enjoyment

Description

Amount of meal (Kcal) consumed up to the level of maximal digestive well-being measured on a - 5 (extremely unpleasant sensation) to + 5 scale (extremely pleasant sensation).

Time Frame

100 minutes

Secondary Outcome Measure Information:

Title

Change in digestive well-being induced by the probe meal

Description

Change in well-being measured by 10 score scales during and after the probe meal.

Time Frame

1 day

Title

Change in fullness sensation induced by the probe meal

Description

Change in fullness sensation measured by 10 score scales during and after the probe meal.

Time Frame

1 day

Title

Change in mood induced by the probe meal

Description

Change in mood measured by 10 score scales during and after the probe meal.

Time Frame

1 day

Title

Change in abdominal discomfort induced by the probe meal

Description

Change in abdominal discomfort measured by 10 score scales during and after the probe meal.

Time Frame

1 day

Title

Change in hunger/satiety induced by the probe meal

Description

Change in hunger/satiety measured by 10 score scales during and after the probe meal.

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria for Patients with Functional Dyspepsia: Rome IV Criteria for Functional Dyspepsia Inclusion Criteria for Healthy Subjects absence of digestive symptoms Exclusion Criteria for all participants: history of anosmia and ageusia alcohol abuse psychological disorders eating disorders Inclusion Criteria for Healthy Subjects: non-obese Exclusion Criteria: history of gastrointestinal symptoms prior obesity use of medications history of anosmia and ageusia current dieting alcohol abuse psychological disorders eating disorders

Facility Information:

Facility Name

Hospital Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

32252402

Citation

Livovsky DM, Pribic T, Azpiroz F. Food, Eating, and the Gastrointestinal Tract. Nutrients. 2020 Apr 2;12(4):986. doi: 10.3390/nu12040986.

Results Reference

result

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Responses to a Comfort Meal in Functional Dyspepsia

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