The primairy goal of the current study is to investigate the effect of enriched nutrition on systemic levels of TNF-alpha.The secundairy goal is to investigate the effect of enriched nutrition on other markers of inflammation, splanchnic perfusion…
ID
Source
Brief title
Condition
- Other condition
- Ancillary infectious topics
Synonym
Health condition
inflammatoire respons op intravasale toediening van endotoxine
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
plasma concentration TNF-alpha
Secondary outcome
inflammatory parameters (CRP, leukocytes, IL-6, IL-8, IL-10)
intestinal epithelial damage (I-FABP)
endothelial activation (adhesion molecules)
Vagal activity (heart rate variability)
Kidney damage (GSTA1-1, GSTP1-1, NGAL, IL-18, KIM-1)
Splanchnic perfusion (gastric tonometry)
Clinical symptoms (e.g. HR, RR, body temperature)
Background summary
Recently it has been demonstrated that the inflammatory response can be
modulated via the vagus nerve. Activation of the vagus nerve exerts
anti-inflammatory effect in vitro and in animal experiments. This vagal
anti-inflammatory pathway is mediated via chloinergic acetylcholine receptors
and hence termed "the cholinergic anti-inflammatory pathway". Activation of
this pathway with enriched nutrition has been demonstrated to attenuate
inflammation and prevent tissue damage in several inflammatory animal models.
The current study investigates the protective effects of enriched nutrition in
a setting of human endotoxemia.
Study objective
The primairy goal of the current study is to investigate the effect of enriched
nutrition on systemic levels of TNF-alpha.
The secundairy goal is to investigate the effect of enriched nutrition on other
markers of inflammation, splanchnic perfusion and sub-clinical organ
dysfunction.
Study design
Placebo-controlled randomised double-blind singel centre intervention study
Intervention
All subjects will recieve an intravenous bolus administration of endotoxin.
Starting 1 hour before and ending 9 hours after endotoxin administration, the
subjects will recieve either enriched enteral nutrition or control enteral
nutrition via a duodenal tube.
Study burden and risks
Intravenous administration of endotoxin is associated with flu-like symptoms,
such as headache, fever, nausea. These complaints will resolve after 4-6 hours.
The administration of endotoxin occurs in a critical care setting under strict
medical supervision.
Postpyloric administration of enteral nutrition is common intervention in
hopitalized patients. The insertion and extraction of a duodenal tube is a
minimal invasive procedure with a very low risk of complications. The presence
of a duodenal tube in the throat results in an uncomfortable feeling. This
sensation usually resolves after half an hour to 1 hour.
Postbus 9101
6500HB Nijmegen
Nederland
Postbus 9101
6500HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
Male
>= 18 years old and <=35 years old
healthy
non-smoking
Exclusion criteria
medication (e.g. NSAID's, antibiotics, gastrointestinal motility agents, corticosteroids)
smoking in the past year
history, signs or symptoms of cardiovascular disease
(family)history of cerebrovascular disease
previous vagal collaps
hypertension
hypotension
renal impairment
liver enzyme abnormalities
positive hepatitis serology
positive HIV test
allergy to milk and/or soy protein
Any gastro-intestinal disease or disorder
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 | NL27963.091.09 |
| Other | www.clinicaltrials.gov |