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The effect of enriched enteral nutrition on inflammation and sub-clinical organ dysfunction during human endotoxemia

The effect of enriched enteral nutrition on inflammation and sub-clinical organ dysfunction during human endotoxemia - Anti-inflammatory effects of enriched enteral nutrition

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33055
Enrollment
26
Registered
2010-01-20
Start date
2010-03-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inflammatoire respons op intravasale toediening van endotoxine infection inflammation

Interventions

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 entera

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male >= 18 years old and

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
plasma concentration TNF-alpha

Secondary

MeasureTime frame
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)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)