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OpenTrials
Completed

NCT Number: NCT00734916

Immune Modulation by Parenteral Lipids

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parenteral lipid emulsion (Omegaven)

Dietary Supplement

Omegaven 10%, 0.2g/kg/hr i.v.during 1 hour on 3 consecutive days

Other names: Omegaven 10%, Fresenius Kabi, Bad Homburg Germany

Parenteral lipid emulsion (Intralipid)

Dietary Supplement

Intralipid 10%, 0.2g/kg/hr i.v. during 1 hour on 3 consecutive days

Other names: Intralipid 10%, Fresenius Kabi, Bad Homburg Germany

Parental lipid emulsion (Saline 0.9%)

Dietary Supplement

Placebo (Saline 0.9%), same volume/hr as lipid emulsions

Other names: lipid free control

Primary outcomes

  1. leukocyte counts

    Time frame: T=0, T=4 days, T=11 days

  2. leukocyte functions

    Time frame: T=0, T=4 days and T=11 days

  3. (anti-)oxidant status

    Time frame: T=0, T=4 days, T=11 days

Secondary outcomes

  1. plasma and leukocyte cell membrane (phospho)lipid composition.

    Time frame: T=0, t=4 and T=11 days

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Aug 14, 2008
Registry last updated
Feb 4, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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