Clinical trial NCT04938934: Conditioning Effect of Previous Symptoms on the Responses to Meal Ingestion
Official title: Factors That Determine the Responses to Meal Ingestion: Conditioning Effect of Previous Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: meal ingestion
postprandial responses
hedonic sensations
homeostatic sensations
Conditioning
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Difference in digestive well-being in response to a comfort meal before and after conditioning.
timeFrame: 120 minutes
Secondary outcomes:
measure: Difference in fullness sensation in response to a comfort meal before and after conditioning
timeFrame: 120 minutes
measure: Change in mood in response to a comfort meal before and after conditioning
timeFrame: 120 minutes
measure: Change in hunger/satiety in response to a comfort meal before and after conditioning
timeFrame: 120 minutes
measure: Change in discomfort in response to a comfort meal before and after conditioning
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
References:
citation: Livovsky DM, Pribic T, Azpiroz F. Food, Eating, and the Gastrointestinal Tract. Nutrients. 2020 Apr 2;12(4):986. doi: 10.3390/nu12040986.
citation: Livovsky DM, Azpiroz F. Gastrointestinal Contributions to the Postprandial Experience. Nutrients. 2021 Mar 10;13(3):893. doi: 10.3390/nu13030893.
citation: 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.