Responses to a Comfort Meal in Functional Dyspepsia

Functional Gastrointestinal Disorders Clinical Trial

Official title:

Factors That Determine the Responses to Meal Ingestion in Functional Dyspepsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04722419
• Other study ID #: PR(AG)338/2016L
• Status: Completed
• Phase: N/A
• Start date: February 2, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2022
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Dyspepsia
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Livovsky DM, Pribic T, Azpiroz F. Food, Eating, and the Gastrointestinal Tract. Nutrients. 2020 Apr 2;12(4). pii: E986. doi: 10.3390/nu12040986. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change in mood induced by the probe meal	Change in mood measured by 10 score scales during and after the probe meal.	1 day
Secondary	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
Secondary	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