Conditioning Effect of Previous Symptoms on the Responses to Meal Ingestion

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT04938934
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.2
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Behavioral: Lipids infusion; Behavioral: Sham infusion	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Factors That Determine the Responses to Meal Ingestion: Conditioning Effect of Previous Symptoms
• Actual Study Start Date: Jun 24, 2021
• Actual Primary Completion Date: Dec 20, 2021
• Actual Study Completion Date: Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aversive conditioning	Behavioral: Lipids infusion; Lipids infusion via intestinal tube
Sham Comparator: Sham conditioning	Behavioral: Sham infusion; Sham infusion via intestinal tube

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Difference in fullness sensation in response to a comfort meal before and after conditioning [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 comfort meal before and after conditioning.

2. Change in mood in response to a comfort meal before and after conditioning [120 minutes]

   Change in mood measured by a 10 cm scale graded from -5 (negative) to +5 (positive) in response to a comfort meal before and after conditioning.

3. Change in hunger/satiety in response to a comfort meal before and after conditioning [120 minutes]

   Change in mood measured by a 10 cm scale graded from -5 (extremely hungry) to +5 (completely satiate) in response to a comfort meal before and after conditioning

4. Change in discomfort in response to a comfort meal before and after conditioning [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 comfort meal before and after conditioning

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Vall d'Hebron	Barcelona		Spain	08035

Sponsors and Collaborators

• Hospital Universitari Vall d'Hebron Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Livovsky DM, Azpiroz F. Gastrointestinal Contributions to the Postprandial Experience. Nutrients. 2021 Mar 10;13(3). pii: 893. doi: 10.3390/nu13030893. Review.
• 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). pii: 658. doi: 10.3390/nu13020658.
• Livovsky DM, Pribic T, Azpiroz F. Food, Eating, and the Gastrointestinal Tract. Nutrients. 2020 Apr 2;12(4). pii: E986. doi: 10.3390/nu12040986. Review.

• Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
• ClinicalTrials.gov Identifier: NCT04938934
• Other Study ID Numbers: PR(AG)338/2016M
• First Posted: Jun 25, 2021
• Last Update Posted: Mar 4, 2022
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hospital Universitari Vall d'Hebron Research Institute: meal ingestion; postprandial responses; hedonic sensations; homeostatic sensations; Conditioning

Study Results

No Results Posted as of Mar 4, 2022