Conditioning Effect of Previous Symptoms on the Responses to Meal Ingestion

Study 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.

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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Behavioral: Lipids infusion
* Behavioral: Sham infusion


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aversive conditioning<br> | Behavioral: Lipids infusion<br>* Lipids infusion via intestinal tube<br>|
| Sham Comparator: Sham conditioning<br> | Behavioral: Sham infusion<br>* Sham infusion via intestinal tube<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
meal ingestion, postprandial responses, hedonic sensations, homeostatic sensations, Conditioning