NCT04938934

Conditioning Effect of Previous Symptoms on the Responses to Meal Ingestion

Factors That Determine the Responses to Meal Ingestion: Conditioning Effect of Previous Symptoms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BEHAVIORAL	Lipids infusion	Lipids infusion via intestinal tube
BEHAVIORAL	Sham infusion	Sham infusion via intestinal tube

Timeline

• Start date: 2021-06-24
• Primary completion: 2021-12-20
• Completion: 2021-12-30
• First posted: 2021-06-25
• Last updated: 2022-03-04

Locations

1 site across 1 country: Spain