Conditioning Effect of Previous Symptoms on the Responses to Meal Ingestion

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: Lipids infusion; Behavioral: Sham infusion

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Aversive conditioning	Behavioral: Lipids infusion; Lipids infusion via intestinal tube
SHAM_COMPARATOR: Sham conditioning	Behavioral: Sham infusion; Sham infusion via intestinal tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in digestive well-being in response to a comfort meal before and after conditioning.	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.	120 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in fullness sensation in response to a comfort meal before and after conditioning	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.	120 minutes
Change in mood in response to a comfort meal before and after conditioning	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.	120 minutes
Change in hunger/satiety in response to a comfort meal before and after conditioning	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	120 minutes
Change in discomfort in response to a comfort meal before and after conditioning	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	120 minutes

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

General Publications

• Livovsky DM, Pribic T, Azpiroz F. Food, Eating, and the Gastrointestinal Tract. Nutrients. 2020 Apr 2;12(4):986. doi: 10.3390/nu12040986.
• Livovsky DM, Azpiroz F. Gastrointestinal Contributions to the Postprandial Experience. Nutrients. 2021 Mar 10;13(3):893. doi: 10.3390/nu13030893.
• Livovsky DM, Barber C, Barba E, Accarino A, Azpiroz F. Abdominothoracic Postural Tone Influences the Sensations Induced by Meal Ingestion. Nutrients. 2021 Feb 18;13(2):658. doi: 10.3390/nu13020658.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 24, 2021
• Primary Completion (ACTUAL): December 20, 2021
• Study Completion (ACTUAL): December 30, 2021

Study Registration Dates

• First Submitted: June 22, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (ACTUAL): June 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Conditioning; meal ingestion; postprandial responses; hedonic sensations; homeostatic sensations
• Other Study ID Numbers: PR(AG)338/2016M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No