Responses to a Comfort Meal in Functional Dyspepsia

Not Applicable

Completed

• Conditions: Functional Gastrointestinal Disorders
• Interventions: Other: Probe meal

• Registration Number: NCT04722419
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-25
• Study Start: 2021-02-02
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-06
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Functional dyspepsia	Probe meal	-
Healthy subjects	Probe meal	-

Primary Outcome Measures

Name	Time	Method
Meal enjoyment	100 minutes	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

Name	Time	Method
Change in fullness sensation induced by the probe meal	1 day	Change in fullness sensation measured by 10 score scales during and after the probe meal.
Change in hunger/satiety induced by the probe meal	1 day	Change in hunger/satiety measured by 10 score scales during and after the probe meal.
Change in digestive well-being induced by the probe meal	1 day	Change in well-being measured by 10 score scales during and after the probe meal.
Change in abdominal discomfort induced by the probe meal	1 day	Change in abdominal discomfort measured by 10 score scales during and after the probe meal.
Change in mood induced by the probe meal	1 day	Change in mood measured by 10 score scales during and after the probe meal.

Trial Locations

Locations (1)

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain