An interventional study of Lipids infusion and Sham infusion in Healthy, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Completed at 1 site in Spain. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-04.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Other
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.
Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Lipids infusion
Behavioral: Sham infusion
Lipids infusion via intestinal tube
Sham infusion via intestinal tube
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.
Time frame: 120 minutes
Difference in fullness sensation in response to a comfort meal before and after conditioning
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.
Time frame: 120 minutes
Change in mood in response to a comfort meal before and after conditioning
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.
Time frame: 120 minutes
Change in hunger/satiety in response to a comfort meal before and after conditioning
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
Time frame: 120 minutes
Change in discomfort in response to a comfort meal before and after conditioning
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
Time frame: 120 minutes
Plan to share: Undecided
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Hospital Universitari Vall d'Hebron Research Institute