EndotoxemiaVIHENCT01100996
Anti-inflammatory Effects of Enriched Enteral Nutrition During Human Experimental Endotoxemia
A study testing enriched enteral feeding in people with Endotoxemia, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endotoxemia
- What is being tested?
- enriched enteral feeding
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥ 18 and ≤ 35 yrs
- Male
- Written informed consent
- non-smoking
Who cannot join
- 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)
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Enriched Enteral Nutrition on Inflammation and Sub-clinical Organ Dysfunction During Human Endotoxemia
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.
- Conditions
- Endotoxemia
- Being tested
- control enteral nutrition, enriched enteral feeding
- Keywords
- enteral nutrition, endotoxemia, innate immunity, nutritional anti-inflammatory pathway, intestinal damage
- Medical subject headings
- Endotoxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control enteral nutritionOther
This feeding consists of 20en% fat, 16en% protein and 49en% carbohydrates
enriched enteral feedingOther
This feeding contains 46 energy percent (en%) fat, 24en% protein and 30en% carbohydrates and is enriched with phospholipids.
| Study group | Role | What they receive |
|---|---|---|
| fasted control | No intervention | Volunteers are fasted for 10 hours and subjected to experimental endotoxemia |
| control feeding | Placebo comparator | Volunteers are fed a control nutrition starting 1 hour prior to LPS administration until 6 hours after LPS Receives: Other: control enteral nutrition |
| enriched feeding | Active comparator | volunteers receive the investigational feeding starting 1 hour prior to LPS administration until 6 hours after LPS Receives: Other: enriched enteral feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
circulating cytokines
Measured: several time points from LPS administration until 24 hours
Secondary outcomes (1)
markers for sub-clinical organ damage (kidney, endothelium, intestine)
Measured: several time points from LPS administration until 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for EndotoxemiaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center
- Investigators
- Johannes Van der Hoeven, PhD, MD, Principal investigator, Department of Intensive Care Medicine, Radboud University Nijmegen Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100996
- Sponsor's protocol ID
- 2009/168
- Acronym
- VIHE
- Status last verified
- Feb 2010
- First submitted
- 7 Apr 2010
- Last updated
- 7 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16216887Luyer 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.
PubMed 19070388de 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.
PubMed 18948813Lubbers 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.
PubMed 19247038
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Enriched Enteral Nutrition on Inflammation and Sub-clinical Organ Dysfunction During Human Endotoxemia
- ClinicalTrials.gov ID
- NCT01100996
- Acronym / sponsor ID
- VIHE / 2009/168
- Conditions
- Endotoxemia
- Keywords
- enteral nutrition, endotoxemia, innate immunity, nutritional anti-inflammatory pathway, intestinal damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center
- Study start
- Feb 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 9 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fasted control | No intervention | –Volunteers are fasted for 10 hours and subjected to experimental endotoxemia |
| control feeding | Placebo comparator | Other: control enteral nutritionVolunteers are fed a control nutrition starting 1 hour prior to LPS administration until 6 hours after LPS |
| enriched feeding | Active comparator | Other: enriched enteral feedingvolunteers receive the investigational feeding starting 1 hour prior to LPS administration until 6 hours after LPS |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age ≥ 18 and ≤ 35 yrs
- Male
- Written informed consent
- non-smoking
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| control enteral nutritionThis feeding consists of 20en% fat, 16en% protein and 49en% carbohydrates | Other | control feeding |
| enriched enteral feedingThis feeding contains 46 energy percent (en%) fat, 24en% protein and 30en% carbohydrates and is enriched with phospholipids. | Other | enriched feeding |
Primary outcome
circulating cytokines
Time frame: several time points from LPS administration until 24 hours
1 secondary outcome
markers for sub-clinical organ damage (kidney, endothelium, intestine)
Time frame: several time points from LPS administration until 24 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2011.
- Background: PubMed 16216887Luyer 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.
- Background: PubMed 19070388Luyer 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.
- Background: PubMed 18948813de 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.
- Background: PubMed 19247038Lubbers 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.
Related trials for Endotoxemia
Recruiting
Short-Chain Fatty Acids in Lypopolysaccharide-Induced Inflammation and Executive Function
Endotoxemia, Inflammation
Not yet recruiting
Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation
Septic Shock
Not yet recruitingObservational study
Intestinal Endotoxemia and Beta- Cell Dysfunction in Prediabetics
Prediabetic State (IGT), Prediabetic State
RecruitingObservational study
OxiCLEAR (Oxiris Cytokines and Endotoxin Adsorption Rate) Study
Sepsis, Septic Shock
Active, not recruiting
Assessing Gut Microbiota Mediated Health Outcomes of Whole Wheat and Its Major Bioactive Components
PreDiabetes, Dysbiosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Van der Hoeven, PhD, MD principal investigator
Department of Intensive Care Medicine, Radboud University Nijmegen Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enriched enteral feeding in people with Endotoxemia, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
circulating cytokines (time frame: several time points from LPS administration until 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01100996, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2011.