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

Radboud University Medical Center36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Endotoxemia

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

circulating cytokines

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

Secondary Outcomes

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

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