NCT04938934

Brief Summary

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.

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 Jun 2021

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

First Submitted

Initial submission to the registry

June 22, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

June 24, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

March 4, 2022

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

June 22, 2021

Last Update Submit

March 3, 2022

Conditions

Healthy

Keywords

meal ingestionpostprandial responseshedonic sensationshomeostatic sensationsConditioning

Outcome Measures

Primary Outcomes (1)

  • Difference in digestive well-being in response to a comfort meal before and after conditioning.

    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 comfort meal before and after conditioning.

    120 minutes

Secondary Outcomes (4)

  • Difference in fullness sensation in response to a comfort meal before and after conditioning

    120 minutes

  • Change in mood in response to a comfort meal before and after conditioning

    120 minutes

  • Change in hunger/satiety in response to a comfort meal before and after conditioning

    120 minutes

  • Change in discomfort in response to a comfort meal before and after conditioning

    120 minutes

Study Arms (2)

Aversive conditioning

EXPERIMENTAL
Behavioral: Lipids infusion

Sham conditioning

SHAM COMPARATOR
Behavioral: Sham infusion

Interventions

Lipids infusionBEHAVIORAL

Lipids infusion via intestinal tube

Aversive conditioning
Sham infusionBEHAVIORAL

Sham infusion via intestinal tube

Sham conditioning

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 (4)

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

    PMID: 32252402BACKGROUND

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

    PMID: 33801924BACKGROUND

  • 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.

    PMID: 33670508BACKGROUND

  • 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: 37242129DERIVED

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

June 22, 2021

First Posted

June 25, 2021

Study Start

June 24, 2021

Primary Completion

December 20, 2021

Study Completion

December 30, 2021

Last Updated

March 4, 2022

Record last verified: 2021-06

Locations

ES(1)