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Completed

NCT Number: NCT04722419

Responses to a Comfort Meal 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.

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Key information

Conditions

Functional Gastrointestinal Disorders Digestive System Diseases Gastrointestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Meal enjoyment

    Time frame: 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 outcomes

  1. Change in digestive well-being induced by the probe meal

    Time frame: 1 day

    Change in well-being measured by 10 score scales during and after the probe meal.

  2. Change in fullness sensation induced by the probe meal

    Time frame: 1 day

    Change in fullness sensation measured by 10 score scales during and after the probe meal.

  3. Change in mood induced by the probe meal

    Time frame: 1 day

    Change in mood measured by 10 score scales during and after the probe meal.

  4. Change in abdominal discomfort induced by the probe meal

    Time frame: 1 day

    Change in abdominal discomfort measured by 10 score scales during and after the probe meal.

  5. Change in hunger/satiety induced by the probe meal

    Time frame: 1 day

    Change in hunger/satiety measured by 10 score scales during and after the probe meal.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Factors That Determine the Responses to Meal Ingestion in Functional Dyspepsia

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 25, 2021
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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