Responses to a Comfort Meal in Functional Dyspepsia

NCT04722419 | Completed

• 1 other identifier: PR(AG)338/2016L
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Gastrointestinal Disorders

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in digestive well-being induced by the probe meal

  1 day

• Change in fullness sensation induced by the probe meal

  1 day

• Change in mood induced by the probe meal

  1 day

• Change in abdominal discomfort induced by the probe meal

  1 day

• Change in hunger/satiety induced by the probe meal

  1 day

Study Arms (2)

Functional dyspepsia

EXPERIMENTAL

Other: Probe meal

Healthy subjects

ACTIVE COMPARATOR

Other: Probe meal

Interventions

Probe meal OTHER

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.

Functional dyspepsia; Healthy subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rome IV Criteria for Functional Dyspepsia
• absence of digestive symptoms

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (1)

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

  PMID: 32252402 RESULT

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 25, 2021
• Study Start: February 2, 2021
• Primary Completion: September 30, 2021
• Study Completion: December 30, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-02

Locations

ES (1)