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


CONCLUSIONS
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.
Fresenius Kabi, Bad Homburg, Germany. ewald.schlotzer@fresenius-kabi.com
Ewald
E
Schlotzer
Ulrike
U
Kanning
D000328:Adult; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004361:Drug Tolerance; D005217:Fat Emulsions, Intravenous / Q000737:chemistry* / Q000493:pharmacokinetics*; D005395:Fish Oils / Q000008:administration & dosage* / Q000378:metabolism; D005990:Glycerol / Q000378:metabolism; D006801:Humans; D008297:Male; D008657:Metabolic Clearance Rate; D000069463:Olive Oil; D010288:Parenteral Nutrition; D010938:Plant Oils / Q000008:administration & dosage* / Q000378:metabolism; D012449:Safety; D013024:Soybean Oil / Q000008:administration & dosage* / Q000378:metabolism; D014280:Triglycerides / Q000097:blood*
D005217:Fat Emulsions, Intravenous; D005395:Fish Oils; D000069463:Olive Oil; D010938:Plant Oils; D014280:Triglycerides; D013024:Soybean Oil; D005990:Glycerol