- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01329965
Safety and Feasibility of an Endotoxemia Model
August 16, 2023 updated by: Penn State University
Safety and Feasibility of an Endotoxemia Model: Pilot Study
The purpose of this study is to establish the safety and feasibility of low dose LPS administration to a small subset of humans in preparation for a larger USDA funded study examining what is the lowest effective dose of EPA + DHA (300, 600, 900 and 1,800 mg/day delivered as fish oil supplements) that significantly attenuates the inflammatory response the investigators wish to examine the effects of an endotoxemia model for inducing inflammation.
Based on previous research, low dose LPS administration affects metabolism in humans with only minimal clinical effects (such as "flu" like illness).
Therefore, each of the six subjects included in this small pilot study will receive a low dose of LPS and placebo in order to learn more about the metabolic changes that occur during administration and inflammation.
The investigators hypothesis that LPS administration will elicit only minimal clinical effects (such as "flu" like illness) when compared to placebo (saline--water with the same amount of salt as in your blood).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
University Park, Pennsylvania, United States, 16802
- Penn State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy men and non-pregnant/lactating women between the ages of 20 and 35 years old
- BMI > 19.9 and < 30.0
- Able to give written informed consent and willing to comply with all study- related procedures
Exclusion Criteria:
- Previous history of heart disease or diabetes
- Renal Insufficiency
- Chronic anti-inflammatory use
- Systolic blood pressure < 90
- Individuals currently using tobacco products or have done so in the previous 30 days
- Individuals taking Omega-3 fatty acid supplements or their usual intake of fish is greater than 3-4 servings per month
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LPS
LPS will be injected at a dose of 0.6 ng/kg body weight through a catheter by a trained GCRC staff member involved with this study.
|
LPS or placebo (saline-salt water) will be injected (at approximately 7:30 am) in this catheter by a trained GCRC staff member involved with this study.
Participants will not be told if they have received the drug or placebo.
The LPS is a sterile solution of protein-free endotoxin which will be injected at a dose of 0.6 ng/kg body weight.
Blood samples will be collected from a venous catheter for the first 12 hours and by venipuncture thereafter.
Subjects will be continuously monitored by trained nursing staff for blood pressure (q 15 minutes) and body temperature (q 30 minutes), and the study will have physician oversight.
|
Placebo Comparator: Saline
A saline solution will be injected through a catheter by a trained GCRC staff member involved with this study.
|
LPS or placebo (saline-salt water) will be injected (at approximately 7:30 am) in this catheter by a trained GCRC staff member involved with this study.
Participants will not be told if they have received the drug or placebo.
The LPS is a sterile solution of protein-free endotoxin which will be injected at a dose of 0.6 ng/kg body weight.
Blood samples will be collected from a venous catheter for the first 12 hours and by venipuncture thereafter.
Subjects will be continuously monitored by trained nursing staff for blood pressure (q 15 minutes) and body temperature (q 30 minutes), and the study will have physician oversight.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Inflammatory Markers
Time Frame: Baseline (before LPS administration), 1, 2, 3, 4, 6, 12, 24 hrs post LPS administration; 2, 3 and 5 days post LPS administration
|
Baseline (before LPS administration), 1, 2, 3, 4, 6, 12, 24 hrs post LPS administration; 2, 3 and 5 days post LPS administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Lipid Mediators
Time Frame: 1, 2, 3 and 5 days post LPS administration
|
1, 2, 3 and 5 days post LPS administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Penny M Kris-Etherton, PhD, RD, Penn State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
April 1, 2011
First Submitted That Met QC Criteria
April 5, 2011
First Posted (Estimated)
April 6, 2011
Study Record Updates
Last Update Posted (Actual)
August 21, 2023
Last Update Submitted That Met QC Criteria
August 16, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PKE LPSpilot
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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