Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500 HB, Netherlands
NCT Number: NCT00734916
Immune modulating properties of parenteral lipid emulsions seem to contribute to the increased risk for infections which remains associated with the use of total parenteral nutrition. Emulsions based on soy bean oil (SO) are the oldest and still most widely used lipid source in TPN formulations but their high content of omega-6 polyunsaturated fatty acids (PUFAs) may be a drawback. Fish oil-based lipid emulsions (FO), rich in omega-3 PUFAs, has been approved for parenteral nutrition in many countries. Mainly retrospective studies on clinical outcomes in septic and postoperative patients have suggested clinical benefits with the inclusion of FO in parenteral nutrition regimens. The exact mechanisms behind the beneficial immunological effects of parenteral FO have, however, not yet been elucidated.
Objective:
To evaluate the effects of intravenous infusion of a FO-based lipid emulsion and a SO-based emulsion on immune function as evidenced by effects on peripheral blood leukocyte counts and functions and on the susceptibility to oxidative stress.
Study design:
Randomized placebo controlled cross-over pilot study with healthy volunteers.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Nijmegen, Gelderland, 6500 HB, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Omegaven 10%, 0.2g/kg/hr i.v.during 1 hour on 3 consecutive days
Other names: Omegaven 10%, Fresenius Kabi, Bad Homburg Germany
Intralipid 10%, 0.2g/kg/hr i.v. during 1 hour on 3 consecutive days
Other names: Intralipid 10%, Fresenius Kabi, Bad Homburg Germany
Placebo (Saline 0.9%), same volume/hr as lipid emulsions
Other names: lipid free control
Time frame: T=0, T=4 days, T=11 days
Time frame: T=0, T=4 days and T=11 days
Time frame: T=0, T=4 days, T=11 days
Time frame: T=0, t=4 and T=11 days
Radboud University Medical Center
Other
Immune Modulation by Omega-3 Versus Omega-6 Based Parenteral Lipids in Healthy Volunteers
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