Immune Modulation by Parenteral Lipids

February 3, 2010 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500 HB
        • Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 3
Placebo
Dietary supplement: Parental lipid emulsion (Saline 0.9%)
Placebo (Saline 0.9%), same volume/hr as lipid emulsions
Other Names:
  • lipid free control
ACTIVE_COMPARATOR: 1
Omegaven 10%
Dietary supplement: Parenteral lipid emulsion (Omegaven)
Omegaven 10%, 0.2g/kg/hr i.v.during 1 hour on 3 consecutive days
Other Names:
  • Omegaven 10%, Fresenius Kabi, Bad Homburg Germany
ACTIVE_COMPARATOR: 2
Intralipid 10%
Dietary supplement: Parenteral lipid emulsion (Intralipid)
Intralipid 10%, 0.2g/kg/hr i.v. during 1 hour on 3 consecutive days
Other Names:
  • Intralipid 10%, Fresenius Kabi, Bad Homburg Germany

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Study Director: Geert JA Wanten, MD, MSc, PhD, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

August 13, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (ESTIMATE)

August 14, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 4, 2010

Last Update Submitted That Met QC Criteria

February 3, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GW/MV/20307
  • CMO 2008/140

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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