To evaluate immune function and (the susceptibility for) oxidative damage under the influence of long-term olive-oil based TPN use in patients without an active underlying disease and compare this with findings in healthy controls
ID
Source
Brief title
Condition
- Malabsorption conditions
- Immune disorders NEC
- Ancillary infectious topics
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Leukocyte counts (with leukocyte differentiation)
Leukocyte functions:
*oxygenradical production by neutrophils
*expression of neutrophil and monocyte cell surface activation markers
*Bacterial killing capacity of neutrophils
*stimulus-induced ex-vivo cytokineproduction by PBMCs
Candidagrowth in cel-free serum
(anti-)oxidant status (Vitamin A,C, E, Selenium, glutathion)
oxidatieve damage (TBARS (indicative for lipid-peroxidation) and protein
carbonyls (indicative for protein damage)
Secondary outcome
none
Background summary
The immune modulating effects of parenteral lipids might contribute to the
increased risk for infectious complications that is associated with the use of
parenteral nutrition. Lipid emulsions based on soy-bean oil (SO) are the oldest
and still most widely used but their high content of omega-6 polyunsaturated
fatty acids (PUFAs), and especially linoleic acid, may be a drawback since the
latter promote the overproduction of arachidonic acid-derived pro-inflammatory
cytokines and eicosanoids. Mainly based on in vitro and animal studies, it has
been suggested that lipid emulsions based on olive oil (OO), rich in the
omega-9 monounsaturated fatty acid oleic acid and with less omega-6 PUFAs,
offer advantages for the use in parenteral nutrition with regard to liver
function, oxidative stress and immune function. Of note, most patients in our
clinic currently use an OO-based lipid emulsion as part of their parenteral
nutrition formulation.
Study objective
To evaluate immune function and (the susceptibility for) oxidative damage under
the influence of long-term olive-oil based TPN use in patients without an
active underlying disease and compare this with findings in healthy controls
Study design
Mono-center patient-control study
Study burden and risks
Prior to the investigation, patients and controls will be screened by medical
history taking. De burden is minimal ans solely exists of one single
venapuncture during which 60 ml of blood will be drawn. The risk for
participation, therefore, is minimal ans solely concerns a possible hematoma at
the puncture site. The TPV-patient already use Clinoleic to full-fill their
nutrtional requirements. No additional investigational product will be
administered.
Postbus 9101
6500 HB
Nederland
Postbus 9101
6500 HB
Nederland
Listed location countries
Age
Inclusion criteria
view page 11 of the protocol
Exclusion criteria
view page 11 of the protocol
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL23940.091.08 |