Long-term efficacy and safety of a new olive oil-based intravenous fat emulsion in pediatric patients: a double-blind randomized study.
BACKGROUND
A new intravenous lipid emulsion (ILE) prepared from a mixture of soybean and olive oils contains only long-chain triacylglycerols, with a low proportion (20%) of polyunsaturated fatty acids and 60% monounsaturated fatty acids.


OBJECTIVE
The goal of this randomized, double-blind clinical trial was to assess in children the efficacy and safety of this new ILE compared with a control group receiving a soybean-oil emulsion.


METHODS
Eighteen children received for 2 mo 24% of nonprotein energy (1.80 g kg (-)(1) d(-)(1)) either as the new ILE or a soybean oil-based emulsion. Assessments were performed on days -30, 0, 30, and 60 and the changes (day 60 - day 0) assessed by analysis of variance.


RESULTS
There were no significant differences in triacylglycerol, apolipoproteins A-I and B, or HDL cholesterol between the 2 groups, whereas total and LDL cholesterol were higher in the soybean oil group on day 60. The pattern of 20:4n-6 in erythrocyte membranes did not change significantly, nor did the ratio of 20:3n-9 to 20:4n-6. On day 60, 18:1n-9 was significantly higher in the olive oil group, the ratio of Sigma(n)-6 > C(18) + 18:3n-6 to 18:2n-6 was 2.20 +/- 0.09 in the olive oil group and 1.33 +/- 0.16 in the soybean-oil group, and Sigma(n)-3 > C(18) was 3.83 +/- 0.30 in the olive oil group and 4. 03 +/- 0.33 in the soybean-oil group. The peroxidation index was lower after the olive oil treatment.


CONCLUSIONS
The olive oil-based emulsion was well tolerated, maintained a normal EFA status, and may be more suitable for prevention of lipid peroxidation than the soybean-oil-based emulsion.
Goulet
O
O
Hôpital des Enfants Malades, Paris, France. olivier.goulet@nck.ap-hop-paris.fr
de Potter
S
S
Antébi
H
H
Driss
F
F
Colomb
V
V
Béréziat
G
G
Alcindor
L G
LG
Corriol
O
O
Le Brun
A
A
Dutot
G
G
Forget
D
D
Perennec
V
V
Ricour
C
C
D002648:Child; D002675:Child, Preschool; D004042:Dietary Fats, Unsaturated / Q000009:adverse effects / Q000494:pharmacology*; D004311:Double-Blind Method; D005217:Fat Emulsions, Intravenous / Q000009:adverse effects / Q000494:pharmacology*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D000069463:Olive Oil; D010288:Parenteral Nutrition; D010938:Plant Oils / Q000009:adverse effects / Q000494:pharmacology*
D004042:Dietary Fats, Unsaturated; D005217:Fat Emulsions, Intravenous; D000069463:Olive Oil; D010938:Plant Oils