Conditioning Effect of Previous Symptoms on the Responses to Meal Ingestion

NCT ID: NCT04938934

Last Updated: 2022-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-24

Study Completion Date

2021-12-30

Brief Summary

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Meal ingestion induces sensations that are influenced by a series of conditioning factors.

Aim: to determine the conditioning effect of previous digestive symptoms to a standardized probe meal.

Controlled randomized parallel study in healthy subjects on the conditioning effect of previous digestive symptoms on the responses to a comfort meal. Digestive symptoms will be induced by lipid (or sham) infusion into the intestine. On three separate days, digestive sensations (satiety, abdominal bloating, digestive well-being, mood, discomfort) in response to a comfort meal will be measured before, during and after the intervention. Primary outcome: effect of conditioning on the sensation of digestive well-being measured by -5 to +5 scale after a comfort meal. Secondary aim: effect of conditioning on abdominal on homeostatic sensations (satiety, fullness, discomfort, nausea).

Participants (16 women, 8 in the intestinal infusion and 8 in the sham intervention) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the comfort meal will be administered 4 h after breakfast. Studies will be conducted in a quiet, isolated room. On each study day, participants will be intubated with a nasoduodenal feeding tube under fluoroscopic control for lipids or sham infusion. A comfort meal will be administered and perception of digestive sensations will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Aversive conditioning

Group Type EXPERIMENTAL

Lipids infusion

Intervention Type BEHAVIORAL

Lipids infusion via intestinal tube

Sham conditioning

Group Type SHAM_COMPARATOR

Sham infusion

Intervention Type BEHAVIORAL

Sham infusion via intestinal tube

Interventions

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Lipids infusion

Lipids infusion via intestinal tube

Intervention Type BEHAVIORAL

Sham infusion

Sham infusion via intestinal tube

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Vall d'Hebron

Barcelona, , Spain

Site Status

Countries

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Spain

References

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Livovsky DM, Pribic T, Azpiroz F. Food, Eating, and the Gastrointestinal Tract. Nutrients. 2020 Apr 2;12(4):986. doi: 10.3390/nu12040986.

Reference Type BACKGROUND
PMID: 32252402 (View on PubMed)

Livovsky DM, Azpiroz F. Gastrointestinal Contributions to the Postprandial Experience. Nutrients. 2021 Mar 10;13(3):893. doi: 10.3390/nu13030893.

Reference Type BACKGROUND
PMID: 33801924 (View on PubMed)

Livovsky DM, Barber C, Barba E, Accarino A, Azpiroz F. Abdominothoracic Postural Tone Influences the Sensations Induced by Meal Ingestion. Nutrients. 2021 Feb 18;13(2):658. doi: 10.3390/nu13020658.

Reference Type BACKGROUND
PMID: 33670508 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37242129 (View on PubMed)

Other Identifiers

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PR(AG)338/2016M

Identifier Type: -

Identifier Source: org_study_id

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