Back to resultsAnti-inflammatory Effects of Enriched Enteral Nutrition During Human Experimental Endotoxemia (VIHE)
Primary Purpose
Endotoxemia
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
control enteral nutrition
enriched enteral feeding
Sponsored by
About this trial
This is an interventional treatment trial for Endotoxemia focused on measuring enteral nutrition, endotoxemia, innate immunity, nutritional anti-inflammatory pathway, intestinal damage
Eligibility Criteria
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
Sites / Locations
- Radboud University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Placebo Comparator
Active Comparator
Arm Label
fasted control
control feeding
enriched feeding
Arm Description
Volunteers are fasted for 10 hours and subjected to experimental endotoxemia
Volunteers are fed a control nutrition starting 1 hour prior to LPS administration until 6 hours after LPS
volunteers receive the investigational feeding starting 1 hour prior to LPS administration until 6 hours after LPS
Outcomes
Primary Outcome Measures
circulating cytokines
Secondary Outcome Measures
markers for sub-clinical organ damage (kidney, endothelium, intestine)
Full Information
NCT ID
NCT01100996
First Posted
April 7, 2010
Last Updated
June 6, 2011
Sponsor
Radboud University Medical Center
Collaborators
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01100996
Brief Title
Anti-inflammatory Effects of Enriched Enteral Nutrition During Human Experimental Endotoxemia
Acronym
VIHE
Official Title
The Effect of Enriched Enteral Nutrition on Inflammation and Sub-clinical Organ Dysfunction During Human Endotoxemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Radboud University Medical Center
Collaborators
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endotoxemia
Keywords
enteral nutrition, endotoxemia, innate immunity, nutritional anti-inflammatory pathway, intestinal damage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
fasted control
Arm Type
No Intervention
Arm Description
Volunteers are fasted for 10 hours and subjected to experimental endotoxemia
Arm Title
control feeding
Arm Type
Placebo Comparator
Arm Description
Volunteers are fed a control nutrition starting 1 hour prior to LPS administration until 6 hours after LPS
Arm Title
enriched feeding
Arm Type
Active Comparator
Arm Description
volunteers receive the investigational feeding starting 1 hour prior to LPS administration until 6 hours after LPS
Intervention Type
Other
Intervention Name(s)
control enteral nutrition
Intervention Description
This feeding consists of 20en% fat, 16en% protein and 49en% carbohydrates
Intervention Type
Other
Intervention Name(s)
enriched enteral feeding
Intervention Description
This feeding contains 46 energy percent (en%) fat, 24en% protein and 30en% carbohydrates and is enriched with phospholipids.
Primary Outcome Measure Information:
Title
circulating cytokines
Time Frame
several time points from LPS administration until 24 hours
Secondary Outcome Measure Information:
Title
markers for sub-clinical organ damage (kidney, endothelium, intestine)
Time Frame
several time points from LPS administration until 24 h
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Van der Hoeven, PhD, MD
Organizational Affiliation
Department of Intensive Care Medicine, Radboud University Nijmegen Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Medical Center
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
16216887
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. doi: 10.1084/jem.20042397. Epub 2005 Oct 10.
Results Reference
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PubMed Identifier
19070388
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.
Results Reference
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PubMed Identifier
18948813
Citation
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.
Results Reference
background
PubMed Identifier
19247038
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.
Results Reference
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Anti-inflammatory Effects of Enriched Enteral Nutrition During Human Experimental Endotoxemia
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