Conditions: Parenteral Nutrition
Keywords: parenteral nutrition lipid emulsion nosocomial infection mortality endothelial function inflammatory markers oxidative stress immune function autonomic nervous system insulin sensitivity carbohydrate metabolism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 100
Healthy volunteers: no

Brief summary:
Many hospitalized patients who are malnourished or not eating receive intravenous feeding or total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase the risk of infections and hospital complications. We do not know why TPN increases hospital complications, but it may be caused by the high sugar or fat content in TPN solutions.

Detailed description:
This study compares the effect of a soybean oil-based versus an olive oil-based lipid emulsion in healthy volunteers and in critically ill patients. In healthy volunteers, your blood sugar levels, blood vessel function, and your ability to fight infections will be examined. In ICU patients, we examines whether use of the olive oil-based lipid emulsion may decrease the risk of infection and hospital complications.

Arms:
arm 1: Subjects who require Total Parenteral Nutrition TPN receiving Intralipid 20% (soybean-based) arm 2: Subjects who require Total Parenteral Nutrition TPN receiving ClinOleic 20% (olive oil based)

Interventions: intervention 1: ClinOleic 20% Intravenous Emulsion intervention 2: Intralipid, 20% Intravenous Emulsion
Intervention descriptions: intervention 1: ClinOleic 20% is a lipid emulsion containing a mixture of refined olive oil (approximately 80%) and refined soybean oil (approximately 20%) corresponding to an essential fatty acid intake of approximately 20% of the total fatty acids intake. intervention 2: It is made up of 20% Soybean oil, 1.2% egg yolk phospholipids, 2.25% glycerin, and water for injection

Protocol document: