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
  Purpose

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 Intervention
Endotoxemia
Other: control enteral nutrition
Other: enriched enteral feeding

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Enriched Enteral Nutrition on Inflammation and Sub-clinical Organ Dysfunction During Human Endotoxemia

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • circulating cytokines [ Time Frame: several time points from LPS administration until 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 36
Study Start Date: February 2010
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100996

Locations
Netherlands
Radboud University Medical Center
Nijmegen, Netherlands, 6525 GA
Sponsors and Collaborators
Radboud University
Maastricht University Medical Center
Investigators
Principal Investigator: Johannes Van der Hoeven, PhD, MD Department of Intensive Care Medicine, Radboud University Nijmegen Medical Center
  More Information

Publications:
Responsible Party: Prof. Dr. J.G. van der Hoeven, Radboud University Nijmegen Medical Center
ClinicalTrials.gov Identifier: NCT01100996     History of Changes
Other Study ID Numbers: 2009/168
Study First Received: April 7, 2010
Last Updated: June 6, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
enteral nutrition
endotoxemia
innate immunity
nutritional anti-inflammatory pathway
intestinal damage

Additional relevant MeSH terms:
Endotoxemia
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014