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Completed

NCT Number: NCT04938934

Conditioning Effect of Previous Symptoms on the Responses to Meal Ingestion

Meal ingestion induces sensations that are influenced by a series of conditioning factors.

Aim: to determine the conditioning effect of previous digestive symptoms to a standardized probe meal.

Controlled randomized parallel study in healthy subjects on the conditioning effect of previous digestive symptoms on the responses to a comfort meal. Digestive symptoms will be induced by lipid (or sham) infusion into the intestine. On three separate days, digestive sensations (satiety, abdominal bloating, digestive well-being, mood, discomfort) in response to a comfort meal will be measured before, during and after the intervention. Primary outcome: effect of conditioning on the sensation of digestive well-being measured by -5 to +5 scale after a comfort meal. Secondary aim: effect of conditioning on abdominal on homeostatic sensations (satiety, fullness, discomfort, nausea).

Participants (16 women, 8 in the intestinal infusion and 8 in the sham intervention) 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 comfort meal will be administered 4 h after breakfast. Studies will be conducted in a quiet, isolated room. On each study day, participants will be intubated with a nasoduodenal feeding tube under fluoroscopic control for lipids or sham infusion. A comfort meal will be administered and perception of digestive sensations will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

Female

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

  • 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

Lipids infusion

Behavioral

Lipids infusion via intestinal tube

Sham infusion

Behavioral

Sham infusion via intestinal tube

Primary outcomes

  1. Difference in digestive well-being in response to a comfort meal before and after conditioning.

    Time frame: 120 minutes

    Change in digestive well-being measured by a 10 cm scale graded from -5 (extremely unpleasant sensation) to +5 (extremely pleasant sensation) in response to a comfort meal before and after conditioning.

Secondary outcomes

  1. Difference in fullness sensation in response to a comfort meal before and after conditioning

    Time frame: 120 minutes

    Change in fullness sensation by a 10 cm scale graded from 0 (not at all) to 10 (very much) in response to a comfort meal before and after conditioning.

  2. Change in mood in response to a comfort meal before and after conditioning

    Time frame: 120 minutes

    Change in mood measured by a 10 cm scale graded from -5 (negative) to +5 (positive) in response to a comfort meal before and after conditioning.

  3. Change in hunger/satiety in response to a comfort meal before and after conditioning

    Time frame: 120 minutes

    Change in mood measured by a 10 cm scale graded from -5 (extremely hungry) to +5 (completely satiate) in response to a comfort meal before and after conditioning

  4. Change in discomfort in response to a comfort meal before and after conditioning

    Time frame: 120 minutes

    Change in the sensation of discomfort by a 10 cm scale graded from 0 (not at all) to 10 (very much) in response to a comfort meal before and after conditioning

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: Conditioning Effect of Previous Symptoms

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 25, 2021
Registry last updated
Mar 4, 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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