Responses to a Comfort Meal in Functional Dyspepsia

Study Overview
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Brief Summary
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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.

Official Title
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Factors That Determine the Responses to Meal Ingestion in Functional Dyspepsia

Conditions
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Functional Gastrointestinal Disorders

Intervention / Treatment
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* Other: Probe meal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional dyspepsia<br> | Other: Probe meal<br>* 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.<br>|
| Active Comparator: Healthy subjects<br> | Other: Probe meal<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postprandial responses, hedonic sensations, homeostatic sensations, functional dyspepsia, meal ingestion