Deconditioning of Acquired Food Aversion

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05897411
• Other study ID #: PR(AG)338/2016N
• Status: Completed
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: May 31, 2023

Study information

• Verified date: May 2023
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 31, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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