Anti-inflammatory Effects of Enriched Enteral Nutrition During Human Experimental Endotoxemia

Not Applicable

Completed

• Conditions: Endotoxemia
• Interventions: Other: control enteral nutrition; Other: enriched enteral feeding

• Registration Number: NCT01100996
• Lead Sponsor: Radboud University Medical Center

Brief Summary

During sepsis and septic shock the immune response can be overwhelming leading to excessive tissue damage, organ failure and death. Ideally, the inflammatory response is modulated leading to both adequate protection to invading pathogens as well as limitation of an exuberant immune response. In the last years, experimental evidence has been accumulating that enteral administration of lipid-enriched nutrition attenuates inflammation and preserves organ integrity in several inflammatory models. The current study investigates the immune-modulating potential of enriched enteral nutrition in a human setting of experimental endotoxemia.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-02
• Study Start: 2010-02
• Study First Submitted: 2010-04-07
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-09
• Primary Completion: 2011-03
• Study Completion: 2011-04
• Last Update Submitted: 2011-06-06
• Last Update Posted: 2011-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

• Age ≥ 18 and ≤ 35 yrs
• Male
• Written informed consent
• non-smoking

Exclusion Criteria

• Use of any medication (e.g. NSAID's, antibiotics, gastrointestinal motility altering medicine, corticosteroids)
• Smoking in the past year
• History, signs or symptoms of cardiovascular disease
• (Family; first degree) history of cerebrovascular disease
• Previous vagal collapse
• Hypertension (defined as RR systolic > 160 or RR diastolic > 90)
• Hypotension (defined as RR systolic < 100 or RR diastolic < 50)
• Renal impairment (defined as plasma creatinin >120 μmol/l)
• Liver enzyme abnormalities ( ASAT > 60 U/L, ALAT > 75 U/L, Gamma-GT > 60 U/L)
• Positive hepatitis serology
• Positive HIV test
• Allergy to milk and/or soy proteins

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control feeding	control enteral nutrition	Volunteers are fed a control nutrition starting 1 hour prior to LPS administration until 6 hours after LPS
enriched feeding	enriched enteral feeding	volunteers receive the investigational feeding starting 1 hour prior to LPS administration until 6 hours after LPS

Primary Outcome Measures

Name	Time	Method
circulating cytokines	several time points from LPS administration until 24 hours

Secondary Outcome Measures

Name	Time	Method
markers for sub-clinical organ damage (kidney, endothelium, intestine)	several time points from LPS administration until 24 h

Trial Locations

Locations (1)

Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands