Immune Modulation by Parenteral Lipids - Full Text View

Sponsored by:	Radboud University
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00734916

Purpose

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	Intervention
Infections Total Parenteral Nutrition	Dietary Supplement: Parenteral lipid emulsion (Omegaven) Dietary Supplement: Parenteral lipid emulsion (Intralipid) Dietary Supplement: Parental lipid emulsion (Saline 0.9%)

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety Study
Official Title:	Immune Modulation by Omega-3 Versus Omega-6 Based Parenteral Lipids in Healthy Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Dietary Supplements Diets

Drug Information available for: Lipids

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:

leukocyte counts [ Time Frame: T=0, T=4 days, T=11 days ] [ Designated as safety issue: Yes ]
leukocyte functions [ Time Frame: T=0, T=4 days and T=11 days ] [ Designated as safety issue: Yes ]
(anti-)oxidant status [ Time Frame: T=0, T=4 days, T=11 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

plasma and leukocyte cell membrane (phospho)lipid composition. [ Time Frame: T=0, t=4 and T=11 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	8
Study Start Date:	August 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Omegaven 10%	Dietary Supplement: Parenteral lipid emulsion (Omegaven) Omegaven 10%, 0.2g/kg/hr i.v.during 1 hour on 3 consecutive days
2: Active Comparator Intralipid 10%	Dietary Supplement: Parenteral lipid emulsion (Intralipid) Intralipid 10%, 0.2g/kg/hr i.v. during 1 hour on 3 consecutive days
3: Placebo Comparator Placebo	Dietary Supplement: Parental lipid emulsion (Saline 0.9%) Placebo (Saline 0.9%), same volume/hr as lipid emulsions

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734916

Contacts

Contact: Michelle WJ Versleijen, MD, MSc	0031-24-3614760	m.versleijen@mdl.umcn.nl
Contact: Geert JA Wanten, MD, MSc, PhD	0031-24-3614760	g.wanten@mdl.umcn.nl

Locations

Netherlands, Gelderland
Radboud University Nijmegen Medical Centre	Recruiting
Nijmegen, Gelderland, Netherlands, 6500 HB
Contact: Michelle WJ Versleijen, MD, MSc 0031-24-3614760 m.versleijen@mdl.umcn.nl

Sponsors and Collaborators

Radboud University

Investigators

Study Director:

Geert JA Wanten, MD, MSc, PhD

Radboud University

More Information

No publications provided

Responsible Party:	Radboud University Nijmegen Medical Centre ( M.W.J. Versleijen, MD, MSc and G.J.A. Wanten, MD, MSc, PhD )
Study ID Numbers:	GW/MV/20307, CMO 2008/140
Study First Received:	August 13, 2008
Last Updated:	February 4, 2009
ClinicalTrials.gov Identifier:	NCT00734916 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:

total parenteral nutrition
infections
Infectious complications related to parenteral nutrition

Study placed in the following topic categories:

Omega 3 Fatty Acid
Healthy

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on September 04, 2009