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Completed

NCT Number: NCT05897411

Deconditioning of Acquired Food Aversion

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.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unmasking previous conditioning procedure

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2023
Registry last updated
Jun 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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