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NCT Number: NCT01100996

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

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Key information

Conditions

Endotoxemia Bacteremia Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Toxemia

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Medical Center

Nijmegen, 6525 GA, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

control enteral nutrition

Other

This feeding consists of 20en% fat, 16en% protein and 49en% carbohydrates

enriched enteral feeding

Other

This feeding contains 46 energy percent (en%) fat, 24en% protein and 30en% carbohydrates and is enriched with phospholipids.

Primary outcomes

  1. circulating cytokines

    Time frame: several time points from LPS administration until 24 hours

Secondary outcomes

  1. markers for sub-clinical organ damage (kidney, endothelium, intestine)

    Time frame: several time points from LPS administration until 24 h

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Maastricht University Medical Center

Registry information

Official study title

The Effect of Enriched Enteral Nutrition on Inflammation and Sub-clinical Organ Dysfunction During Human Endotoxemia

Acronym: VIHE

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 9, 2010
Registry last updated
Jun 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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