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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Endotoxemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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fasted control

Volunteers are fasted for 10 hours and subjected to experimental endotoxemia

Group Type NO_INTERVENTION

No interventions assigned to this group

control feeding

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

Group Type PLACEBO_COMPARATOR

control enteral nutrition

Intervention Type OTHER

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

enriched feeding

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

Group Type ACTIVE_COMPARATOR

enriched enteral feeding

Intervention Type OTHER

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

Interventions

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control enteral nutrition

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

Intervention Type OTHER

enriched enteral feeding

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes