Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CMO 2008/140 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Omegaven 10% |
|
| 2 | Active Comparator | Intralipid 10% |
|
| 3 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parenteral lipid emulsion (Omegaven) | Dietary Supplement | Omegaven 10%, 0.2g/kg/hr i.v.during 1 hour on 3 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| leukocyte counts | T=0, T=4 days, T=11 days | |
| leukocyte functions | T=0, T=4 days and T=11 days | |
| (anti-)oxidant status | T=0, T=4 days, T=11 days |
| Measure | Description | Time Frame |
|---|---|---|
| plasma and leukocyte cell membrane (phospho)lipid composition. | T=0, t=4 and T=11 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Geert JA Wanten, MD, MSc, PhD | Radboud University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Nijmegen Medical Centre | Nijmegen | Gelderland | 6500 HB | Netherlands |
Not provided
| ID | Term |
|---|---|
| D007239 | Infections |
| D006963 | Hyperphagia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C568345 | fish oil triglycerides |
| C545823 | soybean oil, phospholipid emulsion |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Parenteral lipid emulsion (Intralipid) | Dietary Supplement | Intralipid 10%, 0.2g/kg/hr i.v. during 1 hour on 3 consecutive days |
|
|
| Parental lipid emulsion (Saline 0.9%) | Dietary Supplement | Placebo (Saline 0.9%), same volume/hr as lipid emulsions |
|
|
| D017670 |
| Sodium Compounds |