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NCT01329965 · ClinicalTrials.gov registry record · Phase 1
Safety and Feasibility of an Endotoxemia Model
A Phase 1 study, sponsored by Penn State University.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01329965 is a Phase 1 study that has completed, run by Penn State University. The registered enrollment target is 6 participants.
The verdict
NCT01329965, a Phase 1 study, has completed, sponsored by Penn State University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
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).
Interventions
- DRUG LPS (reference endotoxin, E. coli O113:H10:K:neg, manufactured under GMP)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2011-04 |
| Est. Completion | 2011-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01329965
The ClinicalTrials.gov registry entry for NCT01329965 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Penn State University, which has 219 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LPS (reference endotoxin, E. coli O113:H10:K:neg, manufactured under GMP) is the first listed.
NCT01329965 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01329965 about?
NCT01329965 is a clinical study titled "Safety and Feasibility of an Endotoxemia Model". 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) th...
What is the current status of trial NCT01329965?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2011-04. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01329965?
The interventions under investigation include: LPS (reference endotoxin, E. coli O113:H10:K:neg, manufactured under GMP) (DRUG).
Who is sponsoring clinical trial NCT01329965?
This trial is sponsored by Penn State University, which has 219 total clinical trials registered on ClinicalTrials.gov.
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