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Conditioning Effect of Previous Symptoms on the Responses to Meal Ingestion

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04938934
Enrollment
12
Registered
2021-06-25
Start date
2021-06-24
Completion date
2021-12-30
Last updated
2022-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

meal ingestion, postprandial responses, hedonic sensations, homeostatic sensations, Conditioning

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.

Interventions

BEHAVIORALLipids infusion

Lipids infusion via intestinal tube

BEHAVIORALSham infusion

Sham infusion via intestinal tube

Sponsors

Hospital Universitari Vall d'Hebron Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Difference in digestive well-being in response to a comfort meal before and after conditioning.120 minutesChange 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

MeasureTime frameDescription
Difference in fullness sensation in response to a comfort meal before and after conditioning120 minutesChange 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.
Change in mood in response to a comfort meal before and after conditioning120 minutesChange 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.
Change in hunger/satiety in response to a comfort meal before and after conditioning120 minutesChange 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
Change in discomfort in response to a comfort meal before and after conditioning120 minutesChange 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026