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Clinical Trials/NCT04938934
NCT04938934
Completed
Not Applicable

Factors That Determine the Responses to Meal Ingestion: Conditioning Effect of Previous Symptoms

Hospital Universitari Vall d'Hebron Research Institute1 site in 1 country12 target enrollmentJune 24, 2021
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Enrollment
12
Locations
1
Primary Endpoint
Difference in digestive well-being in response to a comfort meal before and after conditioning.
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 24, 2021
End Date
December 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Change in mood in response to a comfort meal before and after conditioning(120 minutes)
  • Change in hunger/satiety in response to a comfort meal before and after conditioning(120 minutes)
  • Difference in fullness sensation in response to a comfort meal before and after conditioning(120 minutes)
  • Change in discomfort in response to a comfort meal before and after conditioning(120 minutes)

Study Sites (1)

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