Immune Modulation by Parenteral Lipids

Official Title: “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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Omegaven 10%
• Active Comparator: 2
  • Intralipid 10%
• Placebo Comparator: 3
  • Placebo

Primary Measures

• leukocyte counts
  • Time Frame: T=0, T=4 days, T=11 days
    Safety Issue?: Yes
• leukocyte functions
  • Time Frame: T=0, T=4 days and T=11 days
    Safety Issue?: Yes
• (anti-)oxidant status
  • Time Frame: T=0, T=4 days, T=11 days
    Safety Issue?: Yes

Secondary Measures

• plasma and leukocyte cell membrane (phospho)lipid composition.
  • Time Frame: T=0, t=4 and T=11 days
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Radboud University Other

Overall Clinical Trial Officials and Contacts

Geert JA Wanten, MD, MSc, PhD Study Director Radboud University  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00734916

Study ID Number: GW/MV/20307

ClinicalTrials.gov Identifier: NCT00734916

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)