Safety and Feasibility of an Endotoxemia Model

The Pennsylvania State University (PENNSTATE)

Status and phase: Completed; Phase 1

Conditions: Inflammation; Cardiovascular Disease

Treatments: Drug: LPS (reference endotoxin, E. coli O113:H10:K:neg, manufactured under GMP)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01329965

PKE LPSpilot

Details and patient eligibility

About

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).

Enrollment: 6 patients

Sex: All

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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6 participants in 2 patient groups, including a placebo group

LPS

Experimental group

Description:

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.

Treatment:

Drug: LPS (reference endotoxin, E. coli O113:H10:K:neg, manufactured under GMP)

Saline

Placebo Comparator group

Description:

A saline solution will be injected through a catheter by a trained GCRC staff member involved with this study.

Treatment:

Drug: LPS (reference endotoxin, E. coli O113:H10:K:neg, manufactured under GMP)