Completed

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

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What is being tested

Parenteral lipid emulsion (Omegaven)

+ Parenteral lipid emulsion (Intralipid)

+ Parental lipid emulsion (Saline 0.9%)

Dietary Supplement
Who is being recruted

Hyperphagia+2

+ Infections

+ Signs and Symptoms

From 18 to 80 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: August 2008
See protocol details

Summary

Principal SponsorRadboud University Medical Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2008

Actual date on which the first participant was enrolled.

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.

Official TitleImmune Modulation by Omega-3 Versus Omega-6 Based Parenteral Lipids in Healthy Volunteers
NCT00734916
Principal SponsorRadboud University Medical Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

8 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HyperphagiaInfectionsSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and Symptoms

Criteria

3 inclusion criteria required to participate
Adult (>18 yrs of age)

Healthy

Willingness to give written informed consent

7 exclusion criteria prevent from participating
Medication use

Smoking > 5 cigarettes/day

Diet with > 2 portions of fatty fish per day

Use of oral fish oil or vitamin substrates

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Omegaven 10%

Group II

Active Comparator
Intralipid 10%

Group III

Placebo
Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Radboud University Nijmegen Medical Centre

Nijmegen, NetherlandsOpen Radboud University Nijmegen Medical Centre in Google Maps
CompletedOne Study Center