Immune Modulation by Parenteral Lipids

Study Overview
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Brief Summary
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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.

Official Title
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Immune Modulation by Omega-3 Versus Omega-6 Based Parenteral Lipids in Healthy Volunteers

Conditions
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Infections, Total Parenteral Nutrition

Intervention / Treatment
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* Dietary Supplement: Parenteral lipid emulsion (Omegaven)
* Dietary Supplement: Parenteral lipid emulsion (Intralipid)
* Dietary Supplement: Parental lipid emulsion (Saline 0.9%)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (>18 yrs of age) Healthy Willingness to give written informed consent Exclusion Criteria: Smoking > 5 cigarettes/day Diet with > 2 portions of fatty fish per day Use of oral fish oil or vitamin substrates History of metabolic disorder (especially diabetes or lipid disorders) History of allergic, inflammatory of immunological disease History of pulmonary, cardiovascular, renal or hematological disease Medication use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Omegaven 10% | Dietary Supplement: Parenteral lipid emulsion (Omegaven)<br>* Omegaven 10%, 0.2g/kg/hr i.v.during 1 hour on 3 consecutive days<br>* Other names: Omegaven 10%, Fresenius Kabi, Bad Homburg Germany;|
| Active Comparator: 2<br>Intralipid 10% | Dietary Supplement: Parenteral lipid emulsion (Intralipid)<br>* Intralipid 10%, 0.2g/kg/hr i.v. during 1 hour on 3 consecutive days<br>* Other names: Intralipid 10%, Fresenius Kabi, Bad Homburg Germany;|
| Placebo Comparator: 3<br>Placebo | Dietary Supplement: Parental lipid emulsion (Saline 0.9%)<br>* Placebo (Saline 0.9%), same volume/hr as lipid emulsions<br>* Other names: lipid free control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| leukocyte counts |  | T=0, T=4 days, T=11 days | 
| leukocyte functions |  | T=0, T=4 days and T=11 days | 
| (anti-)oxidant status |  | T=0, T=4 days, T=11 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma and leukocyte cell membrane (phospho)lipid composition. |  | T=0, t=4 and T=11 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total parenteral nutrition, infections, Infectious complications related to parenteral nutrition