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Clinical Trials/NCT05897411
NCT05897411
Completed
Not Applicable

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

Hospital Universitari Vall d'Hebron Research Institute1 site in 1 country12 target enrollmentJanuary 10, 2023
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Enrollment
12
Locations
1
Primary Endpoint
Difference in postprandial fullness sensation before and after conditioning
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 10, 2023
End Date
May 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Difference in postprandial fullness sensation before and after conditioning

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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