Immune Modulation by Parenteral Lipids

Not Applicable

Completed

• Conditions: Infections; Total Parenteral Nutrition
• Interventions: Dietary Supplement: Parenteral lipid emulsion (Omegaven); Dietary Supplement: Parenteral lipid emulsion (Intralipid); Dietary Supplement: Parental lipid emulsion (Saline 0.9%)

• Registration Number: NCT00734916
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Primary Completion: 2009-08
• Status Verified: 2010-02
• Study Completion: 2010-02
• Last Update Submitted: 2010-02-03
• Last Update Posted: 2010-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Parenteral lipid emulsion (Omegaven)	Omegaven 10%
2	Parenteral lipid emulsion (Intralipid)	Intralipid 10%
3	Parental lipid emulsion (Saline 0.9%)	Placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
plasma and leukocyte cell membrane (phospho)lipid composition.	T=0, t=4 and T=11 days

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Gelderland, Netherlands