Deconditioning of Acquired Food Aversion

Study Overview
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Brief Summary
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Background. Aversive conditioning impairs the rewarding value of a comfort meal. Our aim is to demonstrate the potential effect of deconditioning to reverse aversive conditioning and restore the hedonic postprandial response. Methods: A sham-controlled, randomised, parallel, single-blind study will be performed on 12 healthy women (6 per group). The rewarding value of a comfort meal will be measured at initial exposure, after aversive conditioning (masked administration of the same meal with a high-fat content) and after a deconditioning intervention (unmasking the aversive conditioning paradigm in the deconditioning group vs sham intervention in the control group). Digestive well-being (primary outcome) will be measured every 10 min before and 60 min after ingestion using graded scales. The effect of deconditioning (change from aversive conditioning to deconditioning) will be compared to sham deconditioning in the control group. Expected results: The comfort meal at first exposure will induce a pleasant postprandial experience, which will be impaired by aversive conditioning; this effect will be reverted by deconditioning and the hedonic value of the comfort meal will be restored.

Official Title
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Factors That Determine the Responses to Meal Ingestion: Deconditioning of Acquired Food Aversion

Conditions
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Healthy

Intervention / Treatment
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* Behavioral: Unmasking previous conditioning procedure
* Behavioral: No unmasking of previous conditioning


Participation Criteria
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Eligibility Criteria
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Inclusion 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
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deconditioning<br> | Behavioral: Unmasking previous conditioning procedure<br>* An explanation of the method for aversive conditioning of the comfort meal (masked administration of the meal with a high fat supplement) will be provided.<br>|
| Sham Comparator: Sham deconditioning<br> | Behavioral: No unmasking of previous conditioning<br>* An explanation of the method for aversive conditioning of the comfort meal (masked administration of the meal with a high fat supplement) will not be provided.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in postprandial digestive well-being before and after deconditioning | 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 probe meal before and after deconditioning. | 120 minutes | 
| Difference in postprandial fullness sensation 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 probe meal before and after conditioning. | 120 minutes | 
| Change in postprandial mood before and after conditioning | Change in mood measured by a 10 cm scale graded from -5 (negative) to +5 (positive) in response to a probe meal before and after conditioning. | 120 minutes | 
| Change in postprandial hunger/satiety 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 probe meal before and after conditioning. | 120 minutes | 
| Change in postprandial discomfort 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 probe meal before and after conditioning | 120 minutes | 

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