Deconditioning of Acquired Food Aversion

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Behavioral: Unmasking previous conditioning procedure; Behavioral: No unmasking of previous conditioning

• Registration Number: NCT05897411
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-10
• Status Verified: 2023-05
• Primary Completion: 2023-05-15
• Study Completion: 2023-05-31
• Study First Submitted: 2023-05-31
• Study First Submitted QC: 2023-05-31
• Last Update Submitted: 2023-05-31
• Study First Posted: 2023-06-09
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deconditioning	Unmasking previous conditioning procedure	-
Sham deconditioning	No unmasking of previous conditioning	-

Primary Outcome Measures

Name	Time	Method
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 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
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.
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.
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.

Trial Locations

Locations (1)

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain