Safety and Feasibility of an Endotoxemia Model

Inflammation Clinical Trial

Official title:

Safety and Feasibility of an Endotoxemia Model: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01329965
• Other study ID #: PKE LPSpilot
• Status: Completed
• Phase: Phase 1
• Start date: April 2011
• Est. completion date: September 2011

Study information

• Verified date: August 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Endotoxemia
• Inflammation

Intervention

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

Locations

Country	Name	City	State
United States	Penn State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	United States Department of Agriculture (USDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Lipid Mediators		1, 2, 3 and 5 days post LPS administration