Safety and Feasibility of an Endotoxemia Model

Phase 1

Completed

• Conditions: Cardiovascular Disease; Inflammation

• Registration Number: NCT01329965
• Lead Sponsor: Penn State University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-06
• Primary Completion: 2011-08
• Study Completion: 2011-09
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Inflammatory Markers	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

Name	Time	Method
Change in Lipid Mediators	1, 2, 3 and 5 days post LPS administration

Trial Locations

Locations (1)

Penn State University; 🇺🇸 University Park, Pennsylvania, United States