Clincosm LogoSign in Get a demo

Immune Modulation by Parenteral Lipids

Sponsor
Radboud University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00734916
Collaborator
(none)
8
Enrollment
1
Location
3
Arms
18
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Parenteral lipid emulsion (Omegaven)
  • Dietary Supplement: Parenteral lipid emulsion (Intralipid)
  • Dietary Supplement: Parental lipid emulsion (Saline 0.9%)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Immune Modulation by Omega-3 Versus Omega-6 Based Parenteral Lipids in Healthy Volunteers
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Aug 1, 2009
Actual Study Completion Date :
Feb 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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

    		•
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. leukocyte counts [T=0, T=4 days, T=11 days]

    2. leukocyte functions [T=0, T=4 days and T=11 days]

    3. (anti-)oxidant status [T=0, T=4 days, T=11 days]

    Secondary Outcome Measures

    1. plasma and leukocyte cell membrane (phospho)lipid composition. [T=0, t=4 and T=11 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Radboud University Nijmegen Medical Centre Nijmegen Gelderland Netherlands 6500 HB

    Sponsors and Collaborators

    • Radboud University Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00734916
    Other Study ID Numbers:
    • GW/MV/20307
    • CMO 2008/140
    First Posted:
    Aug 14, 2008
    Last Update Posted:
    Feb 4, 2010
    Last Verified:
    Feb 1, 2010
    Keywords provided by , ,
    total parenteral nutrition
    infections
    Infectious complications related to parenteral nutrition
    Additional relevant MeSH terms:
    Infections
    Soybean oil, phospholipid emulsion

    Study Results

    No Results Posted as of Feb 4, 2010