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

Abstract

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.

• Authors: Ewald Schlotzer, Ulrike Kanning
• Journal: Annals of nutrition & metabolism (Ann Nutr Metab) Vol. 48 Issue 4 Pg. 263-8 ( 2004) ISSN: 0250-6807 [Print] Switzerland
• PMID: 15331886 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Journal Article, Randomized Controlled Trial)
• Copyright: Copyright (c) 2004 S. Karger AG, Basel.

Chemical References

• Fat Emulsions, Intravenous
• Fish Oils
• Olive Oil
• Plant Oils
• Triglycerides
• Soybean Oil
• Glycerol

Topics

• Adult
• Cross-Over Studies
• Double-Blind Method
• Drug Tolerance
• Fat Emulsions, Intravenous (chemistry, pharmacokinetics)
• Fish Oils (administration & dosage, metabolism)
• Glycerol (metabolism)
• Humans
• Male
• Metabolic Clearance Rate
• Olive Oil
• Parenteral Nutrition
• Plant Oils (administration & dosage, metabolism)
• Safety
• Soybean Oil (administration & dosage, metabolism)
• Triglycerides (blood)