NCT05897411

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
Last Updated

June 9, 2023

Status Verified

May 1, 2023

Enrollment Period

4 months

First QC Date

May 31, 2023

Last Update Submit

May 31, 2023

Conditions

Healthy

Keywords

meal ingestionpostprandial responseshedonic sensationshomeostatic sensationsdeconditioning

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Deconditioning

EXPERIMENTAL
Behavioral: Unmasking previous conditioning procedure

Sham deconditioning

SHAM COMPARATOR
Behavioral: No unmasking of previous conditioning

Interventions

Unmasking previous conditioning procedureBEHAVIORAL

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.

Deconditioning
No unmasking of previous conditioningBEHAVIORAL

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.

Sham deconditioning

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • non-obese

You may not qualify if:

  • history of gastrointestinal symptoms
  • prior obesity
  • use of medications
  • history of anosmia and ageusia
  • current dieting
  • alcohol abuse
  • psychological disorders
  • eating disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (2)

  • 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.

    PMID: 37242129BACKGROUND

  • Nieto A, Livovsky DM, Azpiroz F. Reversal of Conditioned Food Aversion Using a Cognitive Intervention: A Sham-Controlled, Randomized, Parallel Study. Nutrients. 2023 Nov 29;15(23):4962. doi: 10.3390/nu15234962.

    PMID: 38068820DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 9, 2023

Study Start

January 10, 2023

Primary Completion

May 15, 2023

Study Completion

May 31, 2023

Last Updated

June 9, 2023

Record last verified: 2023-05

Locations

ES(1)