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

This study has been completed.
Sponsor:
Collaborator:
Maastricht University Medical Center
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT01100996
First received: April 7, 2010
Last updated: June 6, 2011
Last verified: February 2010

April 7, 2010
June 6, 2011
February 2010
March 2011   (final data collection date for primary outcome measure)
circulating cytokines [ Time Frame: several time points from LPS administration until 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01100996 on ClinicalTrials.gov Archive Site
markers for sub-clinical organ damage (kidney, endothelium, intestine) [ Time Frame: several time points from LPS administration until 24 h ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Anti-inflammatory Effects of Enriched Enteral Nutrition During Human Experimental Endotoxemia
The Effect of Enriched Enteral Nutrition on Inflammation and Sub-clinical Organ Dysfunction During Human Endotoxemia

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Endotoxemia
  • Other: control enteral nutrition
    This feeding consists of 20en% fat, 16en% protein and 49en% carbohydrates
  • Other: enriched enteral feeding
    This feeding contains 46 energy percent (en%) fat, 24en% protein and 30en% carbohydrates and is enriched with phospholipids.
  • No Intervention: fasted control
    Volunteers are fasted for 10 hours and subjected to experimental endotoxemia
  • Placebo Comparator: control feeding
    Volunteers are fed a control nutrition starting 1 hour prior to LPS administration until 6 hours after LPS
    Intervention: Other: control enteral nutrition
  • Active Comparator: enriched feeding
    volunteers receive the investigational feeding starting 1 hour prior to LPS administration until 6 hours after LPS
    Intervention: Other: enriched enteral feeding

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
April 2011
March 2011   (final data collection date for primary outcome measure)

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
Male
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01100996
2009/168
Yes
Prof. Dr. J.G. van der Hoeven, Radboud University Nijmegen Medical Center
Radboud University
Maastricht University Medical Center
Principal Investigator: Johannes Van der Hoeven, PhD, MD Department of Intensive Care Medicine, Radboud University Nijmegen Medical Center
Radboud University
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP