Conditioning Effect of Previous Symptoms on the Responses to Meal Ingestion

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT04938934
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-22
• Study First Submitted QC: 2021-06-22
• Study Start: 2021-06-24
• Study First Posted: 2021-06-25
• Primary Completion: 2021-12-20
• Study Completion: 2021-12-30
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference in digestive well-being in response to a comfort meal before and after conditioning.	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 Outcome Measures

Name	Time	Method
Change in mood in response to a comfort meal before and after conditioning	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.
Change in hunger/satiety in response to a comfort meal before and after conditioning	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
Difference in fullness sensation in response to a comfort meal before and after conditioning	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.
Change in discomfort in response to a comfort meal before and after conditioning	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

Trial Locations

Locations (1)

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain