Responses to a Comfort Meal in Functional Dyspepsia

Factors That Determine the Responses to Meal Ingestion in Functional Dyspepsia

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.

Study Overview

• Status: Completed
• Conditions: Functional Gastrointestinal Disorders
• Intervention / Treatment: Other: Probe meal

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Healthy subjects	Other: Probe meal; 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.
EXPERIMENTAL: Functional dyspepsia	Other: Probe meal; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	100 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day
Change in fullness sensation induced by the probe meal	Change in fullness sensation measured by 10 score scales during and after the probe meal.	1 day
Change in mood induced by the probe meal	Change in mood measured by 10 score scales during and after the probe meal.	1 day
Change in abdominal discomfort induced by the probe meal	Change in abdominal discomfort measured by 10 score scales during and after the probe meal.	1 day
Change in hunger/satiety induced by the probe meal	Change in hunger/satiety measured by 10 score scales during and after the probe meal.	1 day

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 2, 2021
• Primary Completion (ACTUAL): September 30, 2021
• Study Completion (ACTUAL): December 30, 2021

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (ACTUAL): January 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 6, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: functional dyspepsia; meal ingestion; postprandial responses; hedonic sensations; homeostatic sensations
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: PR(AG)338/2016L

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No