Elimination and tolerance of a new parenteral lipid emulsion (SMOF) -- a double-blind cross-over study in healthy male volunteers

• Published in: Annals of nutrition and metabolism Vol. 48; no. 4; pp. 263 - 268
• Main Authors: Schlotzer, Ewald, Kanning, Ulrike
• Format: Journal Article
• Language: English
• Published: Basel, Switzerland S. Karger AG 01.01.2004; Karger
• Subjects: Adult; adverse effects; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; blood lipids; Body weight; cholesterol; clinical nutrition; clinical trials; Cross-Over Studies; Double-Blind Method; Drug Tolerance; Emergency and intensive care: metabolism and nutrition disorders. Enteral and parenteral nutrition; Emulsions; excretion; Fat Emulsions, Intravenous - chemistry; Fat Emulsions, Intravenous - pharmacokinetics; fat intake; Fish oils; Fish Oils - administration & dosage; Fish Oils - metabolism; free fatty acids; glycerol; Glycerol - metabolism; hematology; Humans; Intensive care medicine; lipid metabolism; lipids; long chain triacylglycerols; Male; Medical sciences; medium chain triacylglycerols; men; Metabolic Clearance Rate; Olea; Olive Oil; Original Paper; parenteral feeding; Parenteral Nutrition; phospholipids; Plant Oils - administration & dosage; Plant Oils - metabolism; Safety; Soybean oil; Soybean Oil - administration & dosage; Soybean Oil - metabolism; Soybeans; triacylglycerols; Triglycerides - blood; urine; volunteers; Lipid emulsion; Long chain triglycerides; Medium chain triglycerides; Parenteral nutrition; α-Tocopherol; Olive oil; Fish oil; Human; Long chain; Volunteer; Vitamin; Elimination; Tolerance; Lipids; Male; Antioxidant; Medium chain; Triglyceride; n-3 fatty acid; Parenteral administration; Emulsion; Double blind study; Unsaturated fatty acid
• ISSN: 0250-6807; 1421-9697
• DOI: 10.1159/000080461

Aims: The objective of this phase I study was to investigate plasma elimination and tolerance of a new lipid emulsion based on soybean oil, medium chain triglycerides (MCT), olive oil and fish oil (SMOF). Methods: In a double-blind, randomized, cross-over study, 12 healthy male subjects received SMOF 20% and a standard soybean oil emulsion (Lipovenoes 20%, both Fresenius Kabi). Lipid emulsions were infused at a rate of 0.125 g fat/kg body weight/h over 6 h. Before, during and up to 24 h after infusion, lipid metabolism parameters and numerous clinical, chemical and hematological parameters, vital signs and local tolerance were determined. Results: Infusion of SMOF induced a less marked increase of serum triglyceride concentration. At the end of infusion, mean serum triglyceride concentration was significantly lower with SMOF (p < 0.05). Triglyceride half-life was significantly shorter for SMOF than for Lipovenoes (p < 0.001). Infusion of SMOF was apparently associated with higher glycerol concentration (NS). Routine laboratory parameters, vital signs and local tolerance showed no evidence of infusion-related abnormalities. Conclusion: SMOF was eliminated significantly faster than the standard lipid emulsion. This is of potential benefit in patients with limited triglyceride elimination capacity. The safety evaluation revealed a good systemic and local tolerance of SMOF.