Immune Modulation by Parenteral Lipids

Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734916
• Other study ID #: GW/MV/20307
• Secondary ID: CMO 2008/140
• Status: Completed
• Phase: N/A
• First received: August 13, 2008
• Last updated: February 3, 2010
• Start date: August 2008
• Est. completion date: February 2010

Study information

• Verified date: February 2010
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infections
• Total Parenteral Nutrition

Intervention

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

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	leukocyte counts		T=0, T=4 days, T=11 days	Yes
Primary	leukocyte functions		T=0, T=4 days and T=11 days	Yes
Primary	(anti-)oxidant status		T=0, T=4 days, T=11 days	Yes
Secondary	plasma and leukocyte cell membrane (phospho)lipid composition.		T=0, t=4 and T=11 days	No