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

Radboud University Medical Center

Status: Completed

Conditions: Endotoxemia

Treatments: Other: enriched enteral feeding; Other: control enteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT01100996

2009/168

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 3 patient groups, including a placebo group

fasted control

No Intervention group

Description:

Volunteers are fasted for 10 hours and subjected to experimental endotoxemia

control feeding

Placebo Comparator group

Description:

Volunteers are fed a control nutrition starting 1 hour prior to LPS administration until 6 hours after LPS

Treatment:

Other: control enteral nutrition

enriched feeding

Active Comparator group

Description:

volunteers receive the investigational feeding starting 1 hour prior to LPS administration until 6 hours after LPS

Treatment:

Other: enriched enteral feeding