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

Endotoxemia Clinical Trial

— VIHE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100996
• Other study ID #: 2009/168
• Status: Completed
• Phase: N/A
• First received: April 7, 2010
• Last updated: June 6, 2011
• Start date: February 2010
• Est. completion date: April 2011

Study information

• Verified date: February 2010
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endotoxemia

Intervention

Other:
• control enteral nutrition
This feeding consists of 20en% fat, 16en% protein and 49en% carbohydrates
• enriched enteral feeding
This feeding contains 46 energy percent (en%) fat, 24en% protein and 30en% carbohydrates and is enriched with phospholipids.

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Center	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

de Haan JJ, Lubbers T, Hadfoune M, Luyer MD, Dejong CH, Buurman WA, Greve JW. Postshock intervention with high-lipid enteral nutrition reduces inflammation and tissue damage. Ann Surg. 2008 Nov;248(5):842-8. doi: 10.1097/SLA.0b013e318188752c. — View Citation

Lubbers T, Luyer MD, de Haan JJ, Hadfoune M, Buurman WA, Greve JW. Lipid-rich enteral nutrition reduces postoperative ileus in rats via activation of cholecystokinin-receptors. Ann Surg. 2009 Mar;249(3):481-7. doi: 10.1097/SLA.0b013e318194d187. — View Citation

Luyer MD, Derikx JP, Beyaert R, Hadfoune M, van Kuppevelt TH, Dejong CH, Heineman E, Buurman WA, Greve JW. High-fat nutrition reduces hepatic damage following exposure to bacterial DNA and hemorrhagic shock. J Hepatol. 2009 Feb;50(2):342-50. doi: 10.1016/j.jhep.2008.08.025. Epub 2008 Nov 8. — View Citation

Luyer MD, Greve JW, Hadfoune M, Jacobs JA, Dejong CH, Buurman WA. Nutritional stimulation of cholecystokinin receptors inhibits inflammation via the vagus nerve. J Exp Med. 2005 Oct 17;202(8):1023-9. Epub 2005 Oct 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	circulating cytokines		several time points from LPS administration until 24 hours	No
Secondary	markers for sub-clinical organ damage (kidney, endothelium, intestine)		several time points from LPS administration until 24 h	No