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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01100996
Recruitment Status : Completed
First Posted : April 9, 2010
Last Update Posted : June 7, 2011
Maastricht University Medical Center
Information provided by:
Radboud University

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.

Condition or disease Intervention/treatment Phase
Endotoxemia Other: control enteral nutrition Other: enriched enteral feeding Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Enriched Enteral Nutrition on Inflammation and Sub-clinical Organ Dysfunction During Human Endotoxemia
Study Start Date : February 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2011

Arm Intervention/treatment
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
Other: control enteral nutrition
This feeding consists of 20en% fat, 16en% protein and 49en% carbohydrates

Active Comparator: enriched feeding
volunteers receive the investigational feeding starting 1 hour prior to LPS administration until 6 hours after LPS
Other: enriched enteral feeding
This feeding contains 46 energy percent (en%) fat, 24en% protein and 30en% carbohydrates and is enriched with phospholipids.

Primary Outcome Measures :
  1. circulating cytokines [ Time Frame: several time points from LPS administration until 24 hours ]

Secondary Outcome Measures :
  1. markers for sub-clinical organ damage (kidney, endothelium, intestine) [ Time Frame: several time points from LPS administration until 24 h ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01100996

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Radboud University Medical Center
Nijmegen, Netherlands, 6525 GA
Sponsors and Collaborators
Radboud University
Maastricht University Medical Center
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Principal Investigator: Johannes Van der Hoeven, PhD, MD Department of Intensive Care Medicine, Radboud University Nijmegen Medical Center
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Responsible Party: Prof. Dr. J.G. van der Hoeven, Radboud University Nijmegen Medical Center Identifier: NCT01100996    
Other Study ID Numbers: 2009/168
First Posted: April 9, 2010    Key Record Dates
Last Update Posted: June 7, 2011
Last Verified: February 2010
Keywords provided by Radboud University:
enteral nutrition
innate immunity
nutritional anti-inflammatory pathway
intestinal damage
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes