Deconditioning of Acquired Food Aversion

Sponsor

Hospital Universitari Vall d'Hebron Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT05897411

Collaborator

(none)

Enrollment

Location

Arms

4.6

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Behavioral: Unmasking previous conditioning procedure Behavioral: No unmasking of previous conditioning	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jan 10, 2023

Actual Primary Completion Date :

May 15, 2023

Actual Study Completion Date :

May 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Deconditioning	Behavioral: Unmasking previous conditioning procedure 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.
Sham Comparator: Sham deconditioning	Behavioral: No unmasking of previous conditioning 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.

Arm

Intervention/Treatment

Experimental: Deconditioning

Behavioral: Unmasking previous conditioning procedure

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.

Sham Comparator: Sham deconditioning

Behavioral: No unmasking of previous conditioning

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.

Outcome Measures

Primary Outcome Measures

Difference in postprandial digestive well-being before and after deconditioning [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 probe meal before and after deconditioning.
Difference in postprandial fullness sensation 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 probe meal before and after conditioning.
Change in postprandial mood 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 probe meal before and after conditioning.
Change in postprandial hunger/satiety 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 probe meal before and after conditioning.
Change in postprandial discomfort 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 probe meal before and after conditioning

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Vall d'Hebron	Barcelona		Spain	08035

Sponsors and Collaborators

Hospital Universitari Vall d'Hebron Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Nieto A, Livovsky DM, Azpiroz F. Conditioning by a Previous Experience Impairs the Rewarding Value of a Comfort Meal. Nutrients. 2023 May 9;15(10):2247. doi: 10.3390/nu15102247.

Responsible Party:

Hospital Universitari Vall d'Hebron Research Institute

ClinicalTrials.gov Identifier:

NCT05897411

Other Study ID Numbers:

PR(AG)338/2016N

First Posted:

Jun 9, 2023

Last Update Posted:

Jun 9, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute

meal ingestion

postprandial responses

hedonic sensations

homeostatic sensations

deconditioning

Study Results

No Results Posted as of Jun 9, 2023